FDA Adverse Event
Malfunction
Summary report: N
GSA900
MDR report key: 156056
·
Received March 11, 1998
Report
- Report Number
- 2183897-1998-00001
- Event Type
- Malfunction
- Date Received
- March 11, 1998
- Date of Event
- October 22, 1997
- Report Date
- March 10, 1998
- Manufacturer
- CROW RIVER INDUSTRIES, INC.
- Product Code
- FNG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
REPORT OF ALLEGED "PT INJURED WHILE USING A CROW RIVER LIFT." VIA LETTER FROM SOURCE. CRI PRELIMINARY DATA FROM INSURANCE CARRIER STATES, "WHILE THE DRIVER WAS LOADING PT AND HIS WHEELCHAIR ONTO THE TRANSGATOR LIFT, THE LIFT ALLEGEDLY COLLAPSED CAUSING PT AND HIS WHEELCHAIR TO FALL OFF THE LIFT AND RECEIVE PERSONAL INJURY. WHILE THE DRIVER WAS ATTEMPTING TO PREVENT PT FROM FALLING, HE DISLOCATED HIS RIGHT SHOULDER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GSA900 | AUTOMATIC VAN LIFT | FNG | CROW RIVER INDUSTRIES, INC. | GSA900 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| O |