BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI AIR

    MDR report key: 13789560 · Received March 16, 2022

    Report

    Report Number
    3012292104-2022-00003
    Event Type
    Malfunction
    Date Received
    March 16, 2022
    Date of Event
    February 14, 2022
    Report Date
    March 16, 2022
    Manufacturer
    ARJO DOMINICAN REPUBLIC
    Product Code
    FMR
    UDI-DI
    05056341675693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MAXI AIR WAS THROWN AWAY BY THE CUSTOMER, THEREFORE NO ARJO INSPECTION WAS POSSIBLE. PRODUCT INSTRUCTION FOR USE (IFU) WARNS USER THAT IN ORDER "TO AVOID THE PATIENT FROM FALLING OR CAREGIVER FROM BEING INJURED, ENSURE THAT THERE ARE TWO OR MORE CAREGIVERS PRESENT DURING THE TRANSFER." THE DOCUMENTS STATES ALSO THAT "IF RECEIVING SURFACE DOES NOT HAVE ANY BED RAIL, THE CAREGIVER ON THE RECEIVING SIDE IS RESPONSIBLE TO MAKE SURE THE PATIENT DOES NOT REACH OUTSIDE THE BOUNDARIES OF THE RECEIVING SURFACE". ADDITIONALLY IT WARNS TO "MAKE SURE THE PATIENT IS CORRECTLY POSITIONED ON THE MAXIAIR MATTRESS. IF THE PATIENT IS INCORRECTLY POSITIONED, THE MAXI AIR MATTRESS CAN TIP OVER DURING THE TRANSFER." THE IFU CONTAINS GRAPHIC IMAGES SHOWING THAT THE PATIENT SHOULD BE POSITIONED IN THE CENTER OF THE MATTRESS. IN THE REPORTED COMPLAINT, PATIENT WAS PLACED ON HER SIDE ON NARROW SURGICAL TABLE AND ON DEFLATED SLIPPERY MAXI AIR WITHOUT THE SUPPORT OF CAREGIVER. SINCE THE PRODUCT WAS DESIGNED FOR LATERAL TRANSFER, THE FABRIC MAY BE PERCEIVED AS SLIPPERY. TOGETHER, THESE FACTORS ARE BELIEVED TO HAVE LED TO THE FALL. IN SUMMARY, THE DEVICE WAS USED FOR A PATIENT HANDLING WHEN AN EVENT OCCURRED AND THEREFORE THE DEVICE PLAYED A ROLE IN THE EVENT. THE SYSTEM WAS NOT EVALUATED BECAUSE IT WAS THROWN AWAY BY THE CUSTOMER, HOWEVER SINCE THE PATIENT FELL FROM THE MATTRESS, THE SYSTEM IS CONSIDERED NOT MEETING ITS PERFORMANCE SPECIFICATION. WE REPORT THIS EVENT BECAUSE OF PATIENT FALL.

    Description of Event or Problem · 0

    ARJO RECEIVED A CUSTOMER COMPLAINT ABOUT MAXI AIR (AIR SUPPLY AND MATTRESS), WHICH IS AN AIR ASSISTED SINGLE PATIENT MULTIPLE USE LATERAL TRANSFER SYSTEM. CUSTOMER REPORTED THAT A PATIENT FELL FROM MAXI AIR WHEN OPERATING ROOM (OR) TEAM ATTEMPTED TO ROLL AN INTUBATED (UNCONSCIOUS) PATIENT ON AN UNINFLATED MAXI AIR MATTRESS AND ON THE SURGICAL TABLE. THE PATIENT HAD BEEN SUPPORTED BY CAREGIVERS ON EACH SIDE OF THE TABLE, BUT WHEN CAREGIVERS ROLLED THE PATIENT ON THE MATTRESS, ONE OF THE CAREGIVERS, AFTER HEARING THAT THE PATIENT IS STABLE, TURNED AWAY FROM THE TABLE. THIS WAS THE MOMENT, WHEN THE PATIENT SLID OFF, WAS CAUGHT BY THE CAREGIVER AND DESCENDED SLOWLY TO THE GROUND ON TOP OF CAREGIVER. CAREGIVER SUSTAINED NOT SERIOUS BACK INJURIES AND AS MEASURES, HE WAS WORKING ON A LIGHT DUTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780619 MAXI AIR DEVICE, TRANSFER, PATIENT, MANUAL FMR ARJO DOMINICAN REPUBLIC MAS014000 05056341675693

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other