FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C1
MDR report key: 17867010
·
Received October 4, 2023
Report
- Report Number
- 3001421318-2023-03445
- Event Type
- Malfunction
- Date Received
- October 4, 2023
- Date of Event
- August 21, 2023
- Report Date
- August 13, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: INSPECTED VENTILATOR FOUND TECHNICAL EVENT-231022 (PEXPVALVE SENSOR DEFECT) VENTILATOR UNABLE TO START VENTILATION. NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: INSPECTED VENTILATOR FOUND TECHNICAL EVENT-231022 (PEXPVALVE SENSOR DEFECT) VENTILATOR UNABLE TO START VENTILATION. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1229273 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 161001 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |