FDA Adverse Event
Injury
Summary report: N
HAMILTON-C1
MDR report key: 19463098
·
Received June 4, 2024
Report
- Report Number
- 3016723884-2024-00008
- Event Type
- Injury
- Date Received
- June 4, 2024
- Date of Event
- May 16, 2024
- Report Date
- June 4, 2024
- Manufacturer
- HAMILTON MEDCIAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CUSTOMER WANTED ON SITE REPAIR/INSPECTION OF HAMILTON C1 SN 40660 BECAUSE RT CLAIMS VENT WENT INTO STANDBY ON IT'S OWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173927 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDCIAL AG | HAMILTON-C1 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |