BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRPAL AIR-ASSISTED TRANSFER PAD 34: X 78"

    MDR report key: 12287282 · Received August 6, 2021

    Report

    Report Number
    12287282
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 28, 2021
    Manufacturer
    AIRPAL, INC.
    Product Code
    FRZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE RECENTLY STARTED USING THE AIRPAL MATS. SEVERAL CONCERNS REGARDING THE MATS. HERE ARE A FEW: EVENT1: NEW AIRPALS ARE VERY SLIPPERY ON THE BEDS. HAD A PATIENT WITH MOBILITY ISSUES TODAY THAT I WAS ASSISTING TO SIT AT THE EDGE OF THE BED. WHEN HE SAT AND SWUNG HIS LEGS TO THE SIDE, THE WHOLE "AIR PAL" MOVED WITH HIS BODY TAKING THE SHEET OFF WITH IT. THE AIR PAL STARTED SLIPPING OFF THE EDGE OF THE BED WHILE THE PATIENT WAS SITTING ON IT. HE DID HAVE ENOUGH STRENGTH TO STAND SO THE MAT COULD BE REMOVED, BUT THIS POTENTIALLY COULD HAVE BEEN A FALL RELATED TO THE AIR PAL AND HOW SLIPPERY THEY ARE. EVEN WHEN YOU WIPE THEM CLEAN, THEY SLIDE ALL OVER THE BED. EVENT2: AIRPAL USED TO TRANSFER PATIENT FROM CART TO BED. INDIVIDUAL WAS LARGER AND AS IT WAS BLOWING UP IT STARTED TO SINK ON ONE SIDE. PATIENT STARTED TO SLID OFF MAT. THIS WOULD HAVE RESULTED IN A FALL IF RN WASN'T AT THE SIDE OF THE PATIENT. (RN FELT THERE WAS A FIRMNESS ISSUE.) ALSO, WHEN DEFLATING IT THE MATTRESS DOESN'T LOWER EVENLY - IT WOBBLES. THE WEIGHT DOES NOT DISTRIBUTE EVENLY. PROVED TO CAUSE INCREASED DIFFICULTY WITH TRANSFERRING. EVENT3: THE NEW AIRPAL MAT DOES NOT DISTRIBUTE WEIGHT EQUALLY. THE PATIENT FELL TO THE RIGHT SIDE NOT TOWARDS THE BED AND FELL TO THE FLOOR WITH MATTRESS BLOWN UP STILL. THE LONG STRAP ON THE SIDE WAS STUCK UNDER THE MATTRESS AND THAT CONTRIBUTED TO THE FALL ALSO, DUE TO IT PULLING AGAINST THE PATIENT GOING TO THE BED. NO INJURY TO PATIENT. STRAPS ARE TOO LONG AND GETTING STUCK UNDER THE MATT AFFECTING THE PT WHEN BEING SLID ONTO THE BED AND DISTRIBUTING THE WEIGHT UNEQUAL. FOLLOW-UP: THE AIRPAL DOES NOT SEEM STEADY: THEY ARE VERY SLICK AND DO NOT TOLERATE WEIGHT ADJUSTMENTS. MANY OTHER STAFF HAVE REPORTED THEIR DISLIKE AND HAVE HAD NEAR MISSES. THERE WERE OTHER INSTANCES WERE THE STRAP GOT WEDGED OR CAUGHT IN A CART. TEAM MEMBERS TESTED IT ON A STAFF MEMBER AFTER THE FALL AND THE NURSE IN THE BED NOTED THE FIRMNESS ISSUE AND HOW WHEN DEFLATED IT SLIDES YOU IN ONE DIRECTION FAST, DUE TO THE SLIPPERY SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187104 AIRPAL AIR-ASSISTED TRANSFER PAD 34: X 78" DEVICE, PATIENT TRANSFER, POWERED FRZ AIRPAL, INC. 34N BLUE

    Patients

    Seq Age Sex Outcome Treatment
    1