FDA Adverse Event
Malfunction
Summary report: N
EZ FLOW 480
MDR report key: 226601
·
Received June 7, 1999
Report
- Report Number
- MW1016485
- Event Type
- Malfunction
- Date Received
- June 7, 1999
- Date of Event
- June 1, 1999
- Report Date
- June 2, 1999
- Manufacturer
- GISH BIOMEDICAL, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EZ FLOW 480 AMBULATORY INFUSION PUMP WOULD ONLY RUN WHEN PLUGGED INTO AC ADAPTER, EVEN WHEN FULLY CHARGED. AS SOON AS THE PUMP IS UNPLUGGED, THE SCREEN IS BLANK AND WILL NOT TURN ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ FLOW 480 | AMBULATORY INFUSION PUMP | FRN | GISH BIOMEDICAL, INC. | 480 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |