FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C1
MDR report key: 19557593
·
Received June 18, 2024
Report
- Report Number
- 3001421318-2024-01436
- Event Type
- Malfunction
- Date Received
- June 18, 2024
- Date of Event
- January 18, 2024
- Report Date
- October 24, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE PART IS THE NEW STOCK, WHICH WE USE ON THE DEVICE SHOWED THE ERROR CODE TF 231013 (QO2 SENSOR DEFECT). FAILURE OCCURS DURING TESTING. NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE PART IS THE NEW STOCK, WHICH WE USE ON THE DEVICE SHOWED THE ERROR CODE TF 231013 (QO2 SENSOR DEFECT) FAILURE OCCURS DURING TESTING. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2322460 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 161001 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |