FDA Adverse Event
Malfunction
Summary report: N
EZ WAY SMART LIFT
MDR report key: 3561930
·
Received January 3, 2014
Report
- Report Number
- MW5033752
- Event Type
- Malfunction
- Date Received
- January 3, 2014
- Date of Event
- December 20, 2013
- Manufacturer
- EZ WAY, INC
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING TWO PERSON EZ WAY LIFT OF (B)(4) ON (B)(6) 2013, EZ WAY LIFT BROKE AT POINT OF WELD ON CROSS-BARS. RESIDENT WAS SAFELY LOWERED BACK TO GROUND AS HE WAS BEING LIFTED FROM THE FLOOR. EZ WAY LIFT HAD RUSTED AT POINT OF WELDING. LIFT WAS NEW WHEN PUT INTO USE IN (B)(6) 2013 AND HAD 551 USES AT TIME OF INCIDENT. DEVICE HAS BEEN REMOVED FROM SERVICE. DATES OF USE: (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4189 | EZ WAY SMART LIFT | EZ LIFT | FSA | EZ WAY, INC | L600PN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |