MalfunctionILZ
PMT HALO VEST
Received Dec 10, 2009
Report 2182979-2009-00004 · MDR key 1571644
Product problems
- Break
- Crack
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT A PT THAT WAS WHEELCHAIR BOUND WAS WEARING A PMT HALO, THE CARDIAC CREASE ON THE HALO CRACKED. CAUSING THE VEST TO BREAK AT THE CREASE. A NEW FRONT PIECE WAS ORDERED AND PLACED ON THE PT. NO SERIOUS HARM OR INJURY OCCURRED TO THE PT.
Additional Manufacturer Narrative
AS THE PT WAS WHEELCHAIR BOUND, ADDED STRESS TO THE FRONT PORTION OF THE VEST WAS INEVITABLE. THE HEALTH PROFESSIONAL SHOULD HAVE ORDERED A CUSTOM VEST TO ENSURE THAT THE FIT OF THE HALO VEST WAS APPROPRIATE TO THE SITUATION.
Remedial action
- Replace