FDA Adverse Event
Injury
Summary report: N
HAMILTON G5 #21
MDR report key: 9166351
·
Received October 7, 2019
Report
- Report Number
- MW5090248
- Event Type
- Injury
- Date Received
- October 7, 2019
- Date of Event
- September 26, 2019
- Report Date
- October 3, 2019
- Manufacturer
- HAMILTON MEDICAL AG / HAMILTON MEDICAL, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
VENT ARM BUMPED SCREEN CAUSING IT TO GO BLANK AND CONTINUOUSLY ALARM; VENTILATOR STILL WORKING PROPERLY. VENT PULLED FROM SERVICE, SENT FOR INVESTIGATION OF ISSUE. NO HARM TO PT. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 957907 | HAMILTON G5 #21 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | HAMILTON MEDICAL AG / HAMILTON MEDICAL, INC. | G5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |