FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 16884253
·
Received May 8, 2023
Report
- Report Number
- 3001421318-2023-01629
- Event Type
- Malfunction
- Date Received
- May 8, 2023
- Date of Event
- April 10, 2023
- Report Date
- May 8, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002813549
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
REPLACED THE OXYGEN QUICK DISCONNECT PORT (LPO) AND CONFIRMED THAT THE LEAK WAS ELIMINATED. PERFORMED MANUFACTURE'S RECOMMENDED CHECKS AND CALIBRATIONS. DEVICE PASSED ALL CHECKS AND TESTS. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: BIOP-MED STATED THAT THE HAMILTON MEDICAL CLINICAL SPECIALIST ENCOUNTERED A LPO PORT LEAK DURING CLINICAL TRAINING AND REQUESTED THAT THE VENTILATOR BE REPAIRED. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600149 | HAMILTON MEDICAL AG | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | HAMILTON-T1 | 07630002813549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |