FDA Adverse Event
Malfunction
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 17709473
·
Received September 8, 2023
Report
- Report Number
- 3001421318-2023-03134
- Event Type
- Malfunction
- Date Received
- September 8, 2023
- Date of Event
- August 11, 2023
- Report Date
- September 8, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800761
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4) . PRESSURE SENSOR DID NEED TO BE REPLACED. UNIT WORKS AND FUNCTIONS AS INTENDED.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: CUSTOMER REPLACED PRESSURE SENSOR ASSEMBLY AROUND JANUARY, IN MAY IT STILL WAS HAVING PROBLEMS WITH PREADING PRESSURES AND QAW. FLOW SENSOR CALIBRATION SEQUENCE IS ABORTED NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1112641 | HAMILTON MEDICAL AG | HAMILTON-MR1 | CBK | HAMILTON MEDICAL AG | HAMILTON-MR1 | 07630002800761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |