BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARIMAXX

    MDR report key: 3883557 · Received June 9, 2014

    Report

    Report Number
    3010048749-2014-00076
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MFG SITE KINETIC CONCEPTS, INC. AS OF (B)(4) 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE: ON (B)(6) 2014, A PT FELL OUT OF A BARIMAXX II/MAXXAIR RENTAL BED. IT WAS REPORTED THAT THE BED WAS PROGRAMMED FOR "TURN ASSIST" AND THE LEFT UPPER SIDE RAIL WAS NOT LOCKED IN AN UPRIGHT POSITION. A PHYSICIAN EXAMINED THE PT FOR INJURIES AND DETERMINED THAT THE PT SUSTAINED BRUISING ON HIS HEAD AND LEFT ARM. IT WAS DETERMINED THAT THE PT ALSO HAD A FRACTURE TO HIS LEFT ARM, HOWEVER, IT WAS NOT KNOWN IF THAT FRACTURE WAS PRE-EXISTING OR A RESULT OF THE FALL. AN ARJOHUNTLEIGH REPRESENTATIVE WENT TO THE FACILITY AND EXAMINED THE BED. IT WAS DETERMINED THAT THE BARIMAXX II BED FRAME WAS AT A 36 DEGREES WIDTH, HOWEVER, THE MAXXAIR OVERLAY'S PUMP WAS SET FOR A 48 DEGREES WIDTH. THE NURSE INDICATED THAT IT WAS NOT UNDERSTOOD WHY THE BED CONTINUED TO "TURN ASSIST" WHILE THE UPPER LEFT SIDE RAIL WAS IN THE DOWN POSITION AS IT WAS THOUGHT THAT THE "TURN ASSIST" WAS NOT ABLE TO BE INITIATED IF ANY OF THE SIDE RAILS WERE IN THE DOWN POSITION. THE NURSE STATED SHE CONFUSED THE BARIMAXX II/MAXXAIR WITH ANOTHER BED WITH A FEATURE THAT WOULD NOT ALLOW "TURN ASSIST" WHEN ANY SIDE RAIL WAS IN THE DOWN POSITION. THE ARJOHUNTLEIGH REPRESENTATIVE INSTRUCTED THE NURSE THAT THE BARIMAXX II/MAXXAIR DID NOT DIFFERENTIATE BETWEEN SIDE RAILS BEING UP OR DOWN. SUBSEQUENTLY THE PT WAS PLACED BACK ON THE BARIMAXX II/ MAXXAIR SURFACE WITH BOTH SETTINGS ON 48 DEGREES AND ALL FOUR SIDE RAILS IN THE UP POSITION. THE PT WAS REPORTED AS BEING IN STABLE CONDITION AND REMAINS ON THE BARIMAXX II/MAXXAIR BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333997 BARIMAXX FNL ARJOHUNTLEIGH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other