FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 16858701
·
Received May 3, 2023
Report
- Report Number
- 3001421318-2023-01610
- Event Type
- Malfunction
- Date Received
- May 3, 2023
- Date of Event
- April 22, 2023
- Report Date
- September 21, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG`S CONCLUSION FOR THIS EVENT: INVESTIGATION ONGOING.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG`S CONCLUSION FOR THIS EVENT: ROOTCAUSE: INSPIRATORY VALVE DEFECTIVE. CORRECTION: REPLACED DEFECTIVE COMPONENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: SUMMARY: VTI / VTE DIFFERENCE, UNSTABLE FLOW CURVE, INCORRECT MEASUREMENT OF THE P/V TOOL CAUSED BY A LEAKAGE IN THE PRESSURE SENSOR ASSEMBLY. DETAILED COMPLAINT AND FAILURE DESCRIPTION: UNRELIABLE PV-TOOL CURVE.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: SUMMARY: VTI / VTE DIFFERENCE, UNSTABLE FLOW CURVE, INCORRECT MEASUREMENT OF THE P/V TOOL CAUSED BY A LEAKAGE IN THE PRESSURE SENSOR ASSEMBLY. DETAILED COMPLAINT AND FAILURE DESCRIPTION: UNRELIABLE PV-TOOL CURVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123850 | HAMILTON MEDICAL AG | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |