FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C1
MDR report key: 18308503
·
Received December 12, 2023
Report
- Report Number
- 3001421318-2023-04137
- Event Type
- Malfunction
- Date Received
- December 12, 2023
- Date of Event
- August 1, 2023
- Report Date
- July 29, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 0
INVESTIGATION ONGOING HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. NO UDI REQUIRED; DEVICE WAS MANUFACTURED BEFORE 2015.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: MESSAGE " TECHNICAL EVENT 231022" (PEXPVALVE SENSOR DEFECT) DISPLAYED ON SCREEN AND SELF TEST FAILED. NO PATIENT HARM OR CONSEQUENCES.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: MESSAGE " TECHNICAL EVENT 231022" (PEXPVALVE SENSOR DEFECT) DISPLAYED ON SCREEN AND SELF TEST FAILED. NO PATIENT HARM OR CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1778785 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 161001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |