FDA Adverse Event
Malfunction
Summary report: N
CIRRUS
MDR report key: 8270127
·
Received January 23, 2019
Report
- Report Number
- 8270127
- Event Type
- Malfunction
- Date Received
- January 23, 2019
- Date of Event
- December 5, 2018
- Report Date
- December 18, 2018
- Manufacturer
- TOLLOS
- Product Code
- FNG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MD
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CEILING LIFT IN THE PATIENT'S ROOM WAS ABOUT TO BE HOOKED UP TO THE PATIENT'S SLING IN ORDER TO GET THE PATIENT BACK TO BED. THE LIFT HAD BEEN CHARGING FOR APPROXIMATELY TWO HOURS PRIOR TO BEING USED, SINCE THE BATTERY WAS DEPLETED. THE LIFT WOULD NOT MOVE UP OR DOWN WHEN CONTROLS WERE PRESSED. WHEN THE NURSE PUSHED THE 'UP' BUTTON, THE LIFT SUDDENLY DROPPED OVER A FOOT, ALMOST HITTING THE PATIENT IN THE HEAD. THE NURSE GRABBED THE METAL PART OF THE LIFT AND KEPT IT FROM HITTING THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63582 | CIRRUS | LIFT, PATIENT | FNG | TOLLOS | 600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31025 DA |