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