FDA Adverse Event
Malfunction
Summary report: N
SARA 3000
MDR report key: 1971752
·
Received January 12, 2011
Report
- Report Number
- 3004468271-2011-00003
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 29, 2010
- Report Date
- January 7, 2011
- Manufacturer
- MEDIBO MEDICAL PRODUCTS NV
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
LIFT WAS BEING USED BY AN AID WHO THE FACILITY MAINTENANCE MGR HAS NOT BEEN ABLE TO IDENTIFY AT THIS TIME. HE WAS TOLD THAT THE LIFT WAS BEING USED AND SOMEONE SMELLED SMOKE SO IT WAS DISCONTINUED. NO KNOWLEDGE OF WHETHER A RESIDENT WAS IN THE LIFT OR NOT. THE BATTERY HAS A LITTLE BUBBLE ON THE LABEL SIDE; NO DISCOLORATION OTHERWISE. THE LIFT HAS NO DISCOLORATION BUT THE LIFTING ARM IS STUCK IN THE FAR NORTH POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SARA 3000 | ACTIVE FLOOR LIFT | FSA | MEDIBO MEDICAL PRODUCTS NV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |