FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION 2001 SYRINGE INFUSION PUMP
MDR report key: 1193084
·
Received October 6, 2008
Report
- Report Number
- 2183502-2008-00294
- Event Type
- Malfunction
- Date Received
- October 6, 2008
- Date of Event
- September 8, 2008
- Report Date
- October 6, 2008
- Manufacturer
- SMITHS MEDICAL MD
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. DURING EVALUATION, THE AUDIBLE ALARM SPEAKER WAS FOUND TO BE WORKING, BUT SOUNDED BAD AND WAS REPLACED. THIS IS BEING MONITORED FOR TRENDS.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE DEVICE HAD A PROBLEM WITH THE CLUTCH. THERE WAS NO PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT. DURING EVALUATION, IT WAS DISCOVERED THAT THE ALARM SOUNDED BAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDFUSION 2001 SYRINGE INFUSION PUMP | SYRINGE INFUSION PUMP | FRN | SMITHS MEDICAL MD | 20001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE |