Tool · Post-Market Surveillance
PSUR Report
The vigilance database section of your PSUR, generated in seconds: FDA MAUDE adverse event trends, recalls, and enforcement classifications for your device and similar devices — with the documented, reproducible methodology auditors ask for.
Reporting period 2024-07 – 2026-06 · FDA data refreshed ~monthly
Product Code: BSZ
FDA class 2
Gas-Machine, Anesthesia
Adverse events in period
16,164
+47% vs. prior period (11,033)
Deaths reported
6
Recalls in period
42
Class I enforcement
38
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Death
6
11
Injury
132
96
Malfunction
16,026
10,924
Not specified
0
2
Most reported coded problems
Top 15Product problems
Count
No Flow
4,059
Therapeutic or Diagnostic Output Failure
1,748
Failure to Run on Battery
1,666
Insufficient Flow or Under Infusion
1,588
Mechanical Problem
1,425
Power Problem
1,106
Electrical /Electronic Property Problem
1,000
Unexpected Therapeutic Results
711
Failure to Deliver
443
Gas Output Problem
397
Gas/Air Leak
315
Failure to Power Up
255
Output Problem
253
Increase in Pressure
240
Unexpected Shutdown
237
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
15,992
Low Oxygen Saturation
53
Insufficient Information
40
Hypoxia
23
Hypoventilation
20
Distress
20
Cardiac Arrest
13
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
10
Nausea
7
Burn(s)
6
Dizziness
4
Capsular Contracture
4
Vomiting
3
Pneumothorax
3
Loss of consciousness
3
Recalls in period
42 total
FDA enforcement classification:
Class I: 38
Class II: 6
Date
Recalling firm
Status
Reason
2026-05-07
Open, Classified
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2026-05-07
Open, Classified
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2025-11-14
Open, Classified
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.
Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation,
manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
2025-11-14
Open, Classified
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.
Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
2025-11-14
Open, Classified
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.
Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation,
manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
2025-10-20
Open, Classified
Potential for anesthesia leakage.
2025-10-20
Open, Classified
Potential for anesthesia leakage.
2025-09-09
Open, Classified
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2025-09-09
Open, Classified
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-03-21
Open, Classified
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
2025-01-15
Open, Classified
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
2024-10-15
Open, Classified
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2024-10-15
Open, Classified
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2024-10-15
Open, Classified
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2024-10-15
Open, Classified
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2024-07-22
Open, Classified
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the
patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe
cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
2024-07-22
Open, Classified
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the
patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe
cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
2024-07-22
Open, Classified
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the
patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe
cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
2024-07-22
Open, Classified
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the
patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe
cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
2024-07-12
Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
Adverse events by year
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Methodology & data provenance
For your PSUR appendixSearch protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code BSZ, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).
Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.
Generated: 2026-07-05 21:24 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.
PSUR database searches, explained
Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").
Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.
Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.