BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARIMAXXII

    MDR report key: 4474816 · Received October 22, 2014

    Report

    Report Number
    3009988881-2014-00003
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BY THE MANUFACTURER ARJOHUNTLEIGH, INC. PLEASE NOTE THAT THE PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MANUFACTURING SITE (B)(4). AS OF NOVEMBER 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE MAXXAIRETS AND MAXXAIR, WE HAVE NOT BEEN ABLE TO FIND ANY SIMILAR FAULT DESCRIPTION COMPARED TO THE SITUATION INVESTIGATED HERE: TURN ASSIST SYSTEM FAILURE. THERE IS NO TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE. BASED ON THE COLLECTED INFORMATION, IT HAS BEEN DETERMINED THAT THE ALLEGED DEVICE MALFUNCTION WAS NOT A CONTRIBUTOR FACTOR IN THE PATIENT'S DEATH. IN THE COMPLAINT AT HAND, ARJOHUNTLEIGH RECEIVED A SWAP REQUEST FROM THE FACILITY AS THE MATTRESS WAS NOT TURNING FROM ONE SIDE LEFT OR RIGHT TO THE OTHER. AN INSPECTION CHECK CONDUCTED AFTER COLLECTING THE SYSTEM (AFTER END OF RENTAL PERIOD) DID NOT REVEAL ANY FAILURES OR ANOMALIES WITHIN THE SYSTEM, THE CLAIMED MALFUNCTION WAS NOT CONFIRMED. THE TURN ASSIST FEATURE AT THE CENTER OF THE INDICATED ISSUE USES THE AIR SUPPLY UNIT TO SLOWLY INFLATE THE APPROPRIATE TURNING BLADDERS TO GENTLY TILT THE PATIENT TO THE LEFT OR RIGHT. THE CYCLE TIME MAY BE SET TO USE THE TURN AS A NURSE ASSIST OR AS A PROGRAMMABLE CONTINUOUS TURN. THE TURN SYSTEM IS USED AS A HELP FOR THE NURSING STAFF WHEN TURNING THE PATIENT FROM SIDE TO SIDE AND THE ARJOHUNTLEIGH TECHNICIAN WHEN CHANGING THE MATTRESS ON THE BED. A MALFUNCTION OF THE TURN ASSIST SYSTEM IS NOT CONSIDERED TO BE SAFETY RELATED, HOWEVER, IT MIGHT CAUSE INCONVENIENCE FOR A USER OR OPERATOR OF THE DEVICE. PLEASE NOTE THAT, TO DATE WE HAVE NOT RECEIVED ANY INFORMATION WHICH WOULD SUGGEST THAT THE PATIENT HARM WOULD BE THE OUTCOME FROM THE ASSIST SYSTEM BEING INOPERABLE. IN SUMMARY, THE DEVICE WAS BEING USED, WHEN THE TURN ASSIST MALFUNCTIONED, AND THEREFORE THE MALFUNCTION OCCURRED DURING PATIENT TREATMENT. IT COULD BE INTERPRETED THAT THE DEVICE CONTRIBUTED TO THE EVENT SINCE THE PATIENT WAS LYING ON THE DEVICE, HOWEVER, WE COULD NOT FIND ANY INDICATION THAT THE DEVICE ACTIVELY CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, IT WAS MERELY PRESENT. THERE IS NO INDICATION THAT CLAIMED MALFUNCTION OF THE TURN ASSIST FEATURE CAUSE OR CONTRIBUTE TO THIS OUTCOME. THE CAUSE OF THAT COULD NOT BE RELATED TO THE USE NOR MALFUNCTION OF THE DEVICE. GIVEN THE CIRCUMSTANCES AND NO PAST SIMILAR EVENTS, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    ARJOHUNTLEIGH RECEIVED A SWAP REQUEST FROM THE CUSTOMER, BECAUSE THE MAXXAIR ETS MATTRESS WAS NOT TURNING TO THE ONE SIDE OR THE OTHER. LATER THE REQUEST WAS CANCELLED DUE TO THE PATIENT'S DEATH (DATE OF DEATH (B)(6) 2014). THERE WERE NO ALLEGATIONS/COMPLAINTS THAT THE PATIENT'S DEATH WAS RELATED TO THE ARJOHUNTLEIGH PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674398 BARIMAXXII IKY ARJOHUNTLEIGH INC. 310400

    Patients

    Seq Age Sex Outcome Treatment
    1 Death