FDA Adverse Event
Malfunction
Summary report: N
EXCELSIOR
MDR report key: 507334
·
Received January 13, 2004
Report
- Report Number
- MW1030830
- Event Type
- Malfunction
- Date Received
- January 13, 2004
- Date of Event
- January 11, 2004
- Report Date
- January 13, 2004
- Manufacturer
- EXCELSIOR MEDICAL CORP
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EXCELSIOR PUMP SHAKING NOT-WORKING PROPERLY, TURNS ITSELF OFF DURING INFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCELSIOR | SYRINGE INFUSION PUMP | FRN | EXCELSIOR MEDICAL CORP | ESP | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 MO |