FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C1
MDR report key: 21077084
·
Received January 6, 2025
Report
- Report Number
- 3001421318-2025-00008
- Event Type
- Malfunction
- Date Received
- January 6, 2025
- Date of Event
- December 21, 2024
- Report Date
- November 21, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002813426
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 0
TECHNICAL EVENT:232056 (PLAUSIBILITY BETWEEN PAMBIENT AND PFILTER FAILED) OCCURRED AT START-UP DURING NON CLINICAL USE. NO PATIENT WAS INVOLVED. THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY TO A PATIENT. THE LOG FILES PROVIDED CONFIRM THE ISSUE. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A DEFECTIVE PFILTER SENSOR. AFTER REPLACING THE PFILTER SENSOR, THE DEVICE WAS RELEASED BACK INTO USE.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING ROUTINE SETUP, TECHNICAL EVENT: 232056 (PLAUSIBILITY BETWEEN PAMBIENT AND PFILTER FAILED) OCCURRED. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 963066 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | F | 07630002813426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |