inforMED
MalfunctionILE

COMFORT RECLINE SPACER H/S- XL

Received Nov 3, 2016 · Event occurred Oct 7, 2016

Report 3007802293-2016-00079 · MDR key 6077668

Device

Generic name

Comfort Recline Sling

Manufacturer

Prism Medical

Model number

8E4230

Product problems

  • Break
  • Torn Material
  • Break
  • Torn Material

Patient

77 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE POMMEL STRAP IS AN OPTIONAL FEATURE ADDED TO THE SLING. IT IS USED TO KEEP THE LEGS SEPARATED. IF IT WERE NOT PRESENT, THE SLING COULD BE USED WITHOUT AFFECTING PATIENT SAFETY. THE POMMEL POUCH COULD BECOME DETACHED IF: GIRTH OF LEG IS TOO LARGE, THE INDIVIDUAL IS NOT CENTERED OR THE WEIGHT SHIFTS DURING LIFTING, THE INDIVIDUAL IS TOO HEAVY, THE POMMEL STRAP HAS BEEN ATTACHED TO A HOOK ON THE CARRY BAR, RATHER THAN BEING LOOPED OVER THE HIP STRAPS AS SHOWN ABOVE. ROOT CAUSE: UNABLE TO ESTABLISH DEFINITIVE ROOT CAUSE OF DETACHMENT FOR RETURNED SLING. CORRECTION: REPLACEMENT SLING WAS SENT TO THE CUSTOMER. CORRECTIVE ACTION: CUSTOMER SERVICE CONTACTED THE CUSTOMER TO SEE IF THEY HAD QUESTIONS ON THE CORRECT METHOD OF USE FOR THE COMFORT RECLINE SPACER SLING AND HOW TO PROPERLY ATTACH THE POMMEL STRAPS AND POUCH. THEY ALSO REMINDED THE CUSTOMER THERE IS AN INSTRUCTIONAL VIDEO ON THE WEBSITE THAT CAN BE VIEWED.

Description of Event or Problem

DURING LIFT, HIP STRAP SNAPPED CAUSING A CHANGE IN POSITION. PATIENT WAS VERY CLOSE TO BED, DIDN'T FALL OUT OF SLING.

Remedial action

  • Replace