FDA Adverse Event
Injury
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3072032
·
Received April 22, 2013
Report
- Report Number
- 3004493922-2013-00880
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 26, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(6) - IT WAS REPORTED BY THE FACILITY STAFF THAT THE RPL600-1 BARIATRIC LIFT ALLEGEDLY HAD THE PIN HOLDING THE HANGER BAR COMING OUT CAUSING THE BAR TO FALL OFF, AND TO DROPLET THE PATIENT, WHO FELL TO THE FLOOR. MEDICAL ATTENTION WAS SOUGHT, AND THE PATIENT HAD BRUISING ON HER BACK. SHOULD WE RECEIVE ADDITIONAL INFORMATION ON THIS EVENT, THIS FILE WILL BE REVISED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172465 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE SUZHOU | RPL600-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |