FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C3
MDR report key: 18137919
·
Received November 15, 2023
Report
- Report Number
- 3001421318-2023-03867
- Event Type
- Malfunction
- Date Received
- November 15, 2023
- Date of Event
- October 11, 2023
- Report Date
- August 16, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002801881
- PMA / PMN Number
- K201306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOWER GENERATES NO FLOW. INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
BLOWER GENERATES NO FLOW. INVESTIGATION IS ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). UDI RELATED DATA QUALITY UPDATES ONLY: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED.
Description of Event or Problem · 0
HAMILTON MEDICAL AG (HMAG) RECEIVED THE FOLLOWING EVENT DESCRIPTION: SELF TEST FAILED AFTER START-UP AND GIVES TECHNICAL FAULT 431002 AND TECHNICAL EVENT 231009, 231003.
Description of Event or Problem · 0
HAMILTON MEDICAL AG (HMAG) RECEIVED THE FOLLOWING EVENT DESCRIPTION: SELF TEST FAILED AFTER START-UP AND GIVES TECHNICAL FAULT (B)(4) AND TECHNICAL EVENT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 913233 | HAMILTON-C3 | HAMILTON-C3 | CBK | HAMILTON MEDICAL AG | 160005 | 07630002801881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |