FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-T1
MDR report key: 19071636
·
Received April 9, 2024
Report
- Report Number
- 3001421318-2024-00866
- Event Type
- Malfunction
- Date Received
- April 9, 2024
- Date of Event
- February 14, 2024
- Report Date
- October 23, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002801850
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). HAMILTON MEDICAL AG COMPLAINT NUMBER: CER 146578 FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D3, 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: ON START UP, STARTED ALARMING THIS MORNING AND WOULDN'T SWITCHED ON. I ONLY SAW IT BLANK AND ALARMING. NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ON START UP, STARTED ALARMING THIS MORNING AND WOULDN'T SWITCHED ON. I ONLY SAW IT BLANK AND ALARMING NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2310046 | HAMILTON-T1 | HAMILTON-T1 | CBK | HAMILTON MEDICAL AG | 161006 | 07630002801850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |