FDA Adverse Event
Malfunction
Summary report: N
NURSE ASSIST, INC
MDR report key: 829388
·
Received August 9, 2005
Report
- Report Number
- 1650927-2005-00004
- Event Type
- Malfunction
- Date Received
- August 9, 2005
- Date of Event
- June 1, 2005
- Report Date
- August 9, 2005
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE LOT OF POWER SUPPLIES USED EXCLUSIVELY FOR THIS FACILITY APPEARS TO HAVE SOME UNIQUE WEAKNESS WITH THE AC BLADE RETENTION. REPLACEMENT SUPPLIES HAVE BEEN SENT TO THE FACILITY AND FURTHER DESIGN ENHANCEMENTS HAVE BEEN INITIATED TO BOLSTER THE RUGGED-NESS OF THE POWER SUPPLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NURSE ASSIST, INC | * | KMI | NURSE ASSIST, INC. | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |