FDA Adverse Event
Malfunction
Summary report: N
EZ STAND
MDR report key: 12420892
·
Received September 3, 2021
Report
- Report Number
- 12420892
- Event Type
- Malfunction
- Date Received
- September 3, 2021
- Date of Event
- August 22, 2021
- Report Date
- August 30, 2021
- Manufacturer
- EZ WAY INC
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
EZ STAND STOPPED WORKING MID TRANSFER LEAVING PATIENT SUSPENDED. STAFF HAD TO MANUALLY TRANSFER PATIENT TO THE CHAIR. UNIT PLACED IN SERVICE IN 2005. UNIT TAKEN OUT OF SERVICE AND EVALUATED BY FACILITIES/BIOMED. PER THEIR REPORT: THIS BATTERY IS PUTTING THE LIFT IN AN E-STOP MODE. THERE IS A RELEASE MECHANISM ON ALL OF THESE UNITS THAT ARE FOR CASES LIKE THIS, I DON'T KNOW HOW AWARE STAFF ARE OF THIS FEATURE OR IF IT IS INCLUDED WITH ANY TRAINING. WE HAVE REMOVED THAT BATTERY FROM SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1322519 | EZ STAND | LIFT, PATIENT, NON-AC-POWERED | FSA | EZ WAY INC | 8993 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |