FDA Adverse Event
Injury
Summary report: N
AESPIRE
MDR report key: 3072348
·
Received April 18, 2013
Report
- Report Number
- 2112667-2013-00007
- Event Type
- Injury
- Date Received
- April 18, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 27, 2013
- Manufacturer
- DATEX-OHMEDA
- Product Code
- BSZ
- PMA / PMN Number
- K973896
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
UNDER EUROPEAN LAW, PT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL BOT BE RELEASED BY THE SITE. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE HOSPITAL ALLEGES THE UNIT STOPPED VENTILATION WITHOUT AN ALARM. THE CLINICIAN REPORTEDLY SWITCHED TO MANUAL MODE OF VENTILATION. PT WAS REPORTEDLY GIVEN A DRUG INJECTION TO ACCELERATE THE HEART. THERE WAS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167052 | AESPIRE | ANESTHESIA MACHINE | BSZ | DATEX-OHMEDA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |