FDA Adverse Event
Death
Summary report: N
HAMILTON MEDICAL AG
MDR report key: 17441567
·
Received August 2, 2023
Report
- Report Number
- 3001421318-2023-02793
- Event Type
- Death
- Date Received
- August 2, 2023
- Date of Event
- December 12, 2022
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002813549
- PMA / PMN Number
- K181216
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION STILL ONGOING.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: A DEATH INCIDENT WAS REPORTED TO REGULATORY AUTHORITY (MHRA). MHRA REF. NUMBER (B)(4). MISSING INFORMATION ON THE DAY OF REPORTING: VENTILATOR SERIAL NUMBER, HOSPITAL NAME, ARE OTHER DEVICES INVOLVED, DID THE VENTILATOR ALARMED FOR ANY TECHNICAL FAULTS VISUALLY OR AUDIBLY. BESIDE THAT THE INITIAL REPORTER CLAIMS TO BE A HEALTHCARE PROFESSIONAL THERE ARE NO FURTHER CONTACT DETAILS AVAILABLE. THIS INCIDENT WAS NOT PREVIOUSLY REPORTED TO HAMILTON MEDICAL UK OR HAMILTON MEDICAL AG. THE POOR INFORMATION AVAILABLE SUGGESTS A POSSIBLE TUBING DISCONNECTION DURING VENTILATION. THE INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1158898 | HAMILTON MEDICAL AG | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | HAMILTON-T1 | 07630002813549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |