FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C1
MDR report key: 18976967
·
Received March 26, 2024
Report
- Report Number
- 3001421318-2024-00723
- Event Type
- Malfunction
- Date Received
- March 26, 2024
- Date of Event
- March 17, 2024
- Report Date
- November 7, 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 Professional
- N
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4) FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: INSPECTED VENTILATOR SHOWING TECHNICAL ERROR 231022 (PEXPVALVE SENSOR DEFECT) NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: INSPECTED VENTILATOR SHOWING TECHNICAL ERROR 231022 (PEXPVALVE SENSOR DEFECT). NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434060 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 161001 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |