FDA Adverse Event
Malfunction
Summary report: N
EZ FLOW 480
MDR report key: 228868
·
Received June 23, 1999
Report
- Report Number
- MW1016605
- Event Type
- Malfunction
- Date Received
- June 23, 1999
- Date of Event
- June 10, 1999
- Report Date
- June 23, 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: PUMP WOULD NOT TURN ON AFTER BEING CHARGED OVERNIGHT. PUMP DEFECTIVE.
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 | 63 YR | Other |