SMALL MOBILE STANDER
Received Oct 3, 2016 · Event occurred Sep 6, 2016
Report 1319061-2016-00002 · MDR key 5994690
Device
Product problems
- Structural Problem
- Defective Device
- Device Operates Differently Than Expected
Patient
6 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CENTER PANEL HAD CRACKED, CAUSING THE BODY SUPPORT TO SEPARATE FROM THE FRAME. IT IS LIKELY THAT THE CRACKS WOULD HAVE BEEN VISIBLE BEFORE THE FAILURE OCCURED. THE PRODUCT MANUAL SAYS: "INSPECT THIS PRODUCT AND ACCESSORIES REGULARLY FOR LOOSE OR MISSING SCREWS, METAL FATIGUE, CRACKS, BROKEN WELDS, MISSING ATTACHMENTS, GENERAL INSTABILITY OR OTHER SIGNS OF EXCESSIVE WEAR. IMMEDIATELY REMOVE THIS PRODUCT FROM USE WHEN ANY CONDITION DEVELOPS THAT MIGHT MAKE OPERATION UNSAFE."
Additional Manufacturer Narrative
THE DEVICE IS ALMOST 20 YEARS OLD, LONG PAST THE DESIGN LIFE OF 5 YEARS. WE ARE WAITING FOR THE RETURN OF THE DEVICE TO CONDUCT FURTHER EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT THE CLIENT WAS USING THE STANDER WHEN A STRUCTURAL COMPONENT OF THE STANDER FAILED, ALLOWING THE BODY SUPPORT TO SEPARATE FROM THE FRAME OF THE STANDER. THE CLIENT REPORTEDLY FELL BACKWARDS AND HIT HIS HEAD, BUT WAS NOT INJURED.