inforMED
MalfunctionFMP

PREVALON AIRTAP PATIENT REPOSITIONING SYSTEM WEDGES

Received Feb 3, 2017 · Event occurred Dec 20, 2016

Report 6300045 · MDR key 6300045

Device

Generic name

Protector, Skin Pressure

Manufacturer

Sage Products Llc

Product problems

  • Inadequate Instructions for Healthcare Professional
  • Off-Label Use

Patient

67 YR

  • Fall
  • Fall

Narrative

Description of Event or Problem

THE FOLLOWING CONCERN WAS REPORTED BY THE MANAGER OF AN ICU UNIT. PATIENT WAS ALERT AND ABLE TO FOLLOW COMMANDS. ALL APPROPRIATE FALL PRECAUTIONS IN PLACE PRIOR TO EVENT. PT HAD BEEN PLACED IN BED CHAIR POSITION AND HAD RECENTLY BEEN ROUNDED UP (5 MINUTES PRIOR). PT SLID DOWN BED AS IT WAS IN BEDCHAIR POSITION AND LANDED ON BACKSIDE ON FLOOR. ONLY POSSIBLE CONTRIBUTING FACTOR NOTED WAS PT WAS ON AIRTAP DEVICE TO ASSIST WITH RE-POSITIONING. POSSIBLY CONTRIBUTED TO PT BEING ABLE TO SLIDE DOWN AND OUT OF BED. NO INJURIES NOTED. THE MANAGER CONTACTED THE REP OF THE COMPANY AND THEY SAID THE AIRTAP REPOSITIONING DEVICE WAS INTENDED FOR LATERAL REPOSITIONING AND HAS NOT BEEN TESTED IN THE SITTING POSITION. IN THE EDUCATION PROVIDED AS AN INSERVICE FROM PREVALON, THE COMPANY DID NOT SPECIFICALLY STATE THAT PATIENTS HAD TO BE FLAT OR WITH HEAD OF BED WITHIN A CERTAIN NUMBER OF DEGREES WHEN USING THE PRODUCT. THE MANAGER SAID THE REP OF PREVALON AIRTRAP WOULD PASS THE INFORMATION ALONG TO THEIR QUALITY ASSURANCE DEPARTMENT.