FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-G5
MDR report key: 19870020
·
Received July 31, 2024
Report
- Report Number
- 3001421318-2024-01815
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- July 24, 2024
- Report Date
- November 19, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002802208
- PMA / PMN Number
- K193228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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). HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D4, G6, H2, H4, H11.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: DURING ROUTINE MAINTENANCE, CUSTOMER SAYS P&T ENCODER WILL REGISTER CW/CCW TURNS BUT NOT REGISTER PRESS/DEPRESS ON SWITCH NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: DURING ROUTINE MAINTENANCE, CUSTOMER SAYS P&T ENCODER WILL REGISTER CW/CCW TURNS BUT NOT REGISTER PRESS/DEPRESS ON SWITCH. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1776655 | HAMILTON-G5 | HAMILTON-G5 | CBK | HAMILTON MEDICAL AG | 159002 | 07630002802208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |