FDA Adverse Event
Malfunction
Summary report: N
TOLLOS
MDR report key: 5018032
·
Received August 20, 2015
Report
- Report Number
- 5018032
- Event Type
- Malfunction
- Date Received
- August 20, 2015
- Date of Event
- July 7, 2015
- Report Date
- July 10, 2015
- Manufacturer
- TOLLOS, INC.
- Product Code
- FNG
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DEVICE IS AN OVERHEAD LIFT MACHINE IN THE PATIENT'S ROOM. PER NURSE (RN) AND PATIENT, THE RN WAS PUSHING THE TOLLOS LIFT TO BACK WALL TO HANG AND THE DEVICE SPARKED AND SMOKED. CHARGE RN NOTIFIED MAINTENANCE. DEVICE WAS NOT BEING USED FOR THIS PATIENT. THE TOLLOS SERVICE REP PERFORMED A SERVICE EVALUATION ON THE LIFT. CORRECTIVE ACTION: "CHECKED ALL FUNCTIONS AND SAW NO PROBLEMS WITH LIFT OR FUNCTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 552447 | TOLLOS | PATIENT LIFT | FNG | TOLLOS, INC. | 60016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |