BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARIMAXXII POWERDRIVE

    MDR report key: 4782423 · Received May 18, 2015

    Report

    Report Number
    3007420694-2015-00100
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Manufacturer
    ARJOHUNTLEIGHT, INC.
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 FOR THE MANUFACTURING SITE KINETICS CONCEPT INC. FROM NOVEMBER 2012 UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJOHUNTLEIGH INC. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4) COMPLAINT HANDLING ESTABLISHMENT. REVIEW OF THE DESIGN OF THE TRAPEZE FRAME ASSEMBLY REVEALED THAT THE CONSTRUCTION ALLOW ONE POSSIBLE WAY OF ASSEMBLY, LIMITING POSSIBILITY OF INCORRECT INSTALLATION. DURING NORMAL OPERATION AND USAGE OF THE TRAPEZE TUBE (AID IN PATIENT IN POSTURING, SITTING, EXITING AND ENTERING THE BED), ALL FORCE APPLIED ARE IN THE DOWNWARD DIRECTION. THE SUPPORT BAR NEED TO BE RAISED OVER 2 INCHES TO BE REMOVED FROM MOUNTING HOLES - THIS SITUATION MAY OCCUR WHEN THE CAREGIVER WANT TO ADJUST THE LOCATION OF THE TRAPEZE BAR, PRIOR TO PATIENT USE, AND INTENTIONALLY LIFT THE PART. THIS SUPPORT THE CONCLUSION OF THE MANUFACTURER REPORT 3007420694-2015-00100 SUBMITTED TO THE FDA ON 06/12/2015, THAT IT SEEMS MOST LIKELY THAT THE DEVICE SUFFERED A MALFUNCTION DUE TO USE ERROR - PATIENT USING THE DEVICE AT THE TIME OF EVENT WAS DESCRIBED BY THE NURSE AS BEING YANKING AND PULLING ON THE TRAPEZE (PATIENT HAS MENTAL ISSUES). THE INFORMATION PROVIDED IN THE REPORT SUBMITTED BEFORE HAS NOT CHANGED AS A RESULT OF THE INFORMATION PRESENTED ABOVE.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE (B)(4) FROM 11/2012 UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJOHUNTLEIGH, INC. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4) COMPLAINT HANDLING ESTABLISHMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE RANGE OF BARIMAXX DEVICES, WE HAVE NOT BEEN ABLE TO FIND ANY OTHER EVENT WITH THE FAULT DESCRIPTIONS COMPARED TO THE SITUATION INVESTIGATED HERE: TRAPEZE CHAIN SUPPORT FELL OFF ON THE PATIENT. THERE IS NO TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE FOR THESE DEVICES. TRAPEZE SYSTEM IS AN OPTIONAL ACCESSORY SUITABLE TO BE USED E.G. WITH THE BARIMAXX II DEVICE, IT IS AN OVERHEAD RAIL SYSTEM WITH A SUSPENDED HANDLE TO AID PATIENT IN REPOSITIONING, SITTING EXITING AND ENTERING THE BED. BASED ON THE INFORMATION COLLECTED TO DATE, THE PROVIDED PROBLEM DESCRIPTION AND THE INSPECTION OF THE DEVICE, WE HAVE BEEN ABLE TO ESTABLISH THE FOLLOWING: THE EVENT WAS NOT WITNESSED BY ANYONE. THE INFORMATION RECEIVED BY THE PATIENT IS THAT SHE PULLED ON THE TRAPEZE AND IT FELL ON HER; THE BARIMAXX II DEVICE IN QUESTION WAS DELIVERED TO THE CUSTOMER TOGETHER WITH THE TRAPEZE ACCESSORY; THE INSTALLATION WAS CONDUCTED BY SERVICE CONSULTANT - (B)(4), WHO CONDUCT ALSO A FULL IN-SERVICE FOR THE ACCOUNT ON THE PROPER USE OF BED AND TRAPEZE; THE PATIENT INVOLVED IN THE EVENT WAS DESCRIBED BY THE NURSE AS BEING YANKING AND PULLING ON THE TRAPEZE (PATIENT HAS A MENTAL CONDITION); WEIGHT OF THE PATIENT USING THE TRAPEZE IS UNKNOWN; AT THE TIME OF THE TECHNICIAN VISIT, THE PART OF THE TRAPEZE WHICH FELL ON THE PATIENT WAS KEPT AT NURSE STATION; ON THE PART INSPECTION, NO SIGN OF BREAKAGE OR DISCONNECTION HAVE BEEN FOUND, THERE WERE NO MISSING OR BROKEN PIECES TO THE TRAPEZE TUBE OR CHAIN, EVERY PIECE WAS INTACT; THE TRAPEZE WAS COMPLETELY IN PLACE AND ONLY 'MISSING' COMPONENT WAS THE TRAPEZE TUBING WITH THE CHAIN WHICH THE NURSE HAD PLACED BEHIND THE DESK; THE TRAPEZE CHAIN SUPPORT ASSEMBLY CAME OUT FROM THE HOLE IN LONG SUPPORT ASSEMBLY TO WHICH IT IS INSTALLED WITH USE OF THE PIN, TWO NUTS AND WASHER. THE PINS THAT GO INTO THE HOLE WERE NOT DAMAGE, SO IT IS UNKNOWN HOW IT CAME OUT; THE PRODUCT USE MANUAL AND ACCESSORY INSTALLATION INSTRUCTION (E.G. #310611-AH REV. A) INCLUDE THE FOLLOW RECOMMENDATION: ALWAYS FOLLOW FACILITY PROTOCOLS WHEN USING AN OVERHEAD PATIENT ASSIST SYSTEM; WHEN PROPERLY INSTALLED, THIS ASSEMBLY IS DESIGNED TO SUPPORT PATIENTS WEIGHING UP TO 1000 LBS (455 KG). HOWEVER, DO NOT PLACE MORE THAN 650 LB (295 KG) STATIC WEIGHT DIRECTLY ON TRAPEZE HANDLE; ONE OF THE STEPS OF THE ACCESS INSTALLATION ARE POSITIONING AND INSTALLING THE TRAPEZE CHAIN SUPPORT ASSEMBLY LENGTH-WISE OVER LEFT/RIGHT LONG SUPPORT WELDMENTS TO ACCOMMODATE PATIENT NEEDS. THERE IS ALSO REQUIREMENT TO CHECK, ADJUST AND SECURELY TIGHTEN ALL ASSEMBLIES. IN SUMMARY, THE DEVICE FAILED TO MEET SPECIFICATIONS, WAS BEING USED AT THE TIME OF THE EVENT FOR PATIENT TREATMENT, AND DUE TO THIS PLAYED A ROLE IN THE INCIDENT. FORTUNATELY, THERE WERE NO SERIOUS INJURIES AS A RESULT OF THE EVENT. IT SEEMS MOST LIKELY THAT THE DEVICE SUFFERED A MALFUNCTION DUE TO USE ERROR - PATIENT USING THE DEVICE AT THE TIME OF THE EVENT WAS DESCRIBED BY THE NURSE AS BEING YANKING AND PULLING ON THE TRAPEZE (PATIENT HAS MENTAL ISSUES). GIVEN THE CIRCUMSTANCES AND THE FACT THAT THIS INCIDENT APPEARS TO BE A REMOTE ONE, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE KINETICS CONCEPTS INC. (UNDER REGISTRATION # (B)(4)). FROM 11/2014 UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJOHUNTLEIGH INC. AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION # (B)(4). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4) COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION # (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322479 BARIMAXXII POWERDRIVE NONE FNL ARJOHUNTLEIGHT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1