BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGEL 5100 SATELLIT CEILING LIFT

    MDR report key: 1375073 · Received April 28, 2009

    Report

    Report Number
    8043351-2009-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2009
    Report Date
    April 28, 2009
    Manufacturer
    HUMAN CARE HC SWEDEN AB
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HUMAN CARE (HC) HAS INITIATED A REPLACEMENT STRATEGY FOR ALL SATELLIT CARRY BARS MANUFACTURED PRIOR TO (B)(6) 2009. HUMAN CARE (B)(4) WILL COORDINATE THE STRATEGY FOR ALL UNITS IN (B)(4) WILL COORDINATE THE STRATEGY IN THE UNITED STATES. HC WILL MANUFACTURER AND TEST 471 NEW CARRY BARS. EACH BAR-END WILL BE EXTERNALLY WELDED AND EACH CARRY BAR WILL BE TESTED TO 115% OF MAXIMUM LOAD CAPACITY. HC WILL PROVIDE MULTIPLE SHIPMENTS OF NEW CARRY BARS TO (B)(4). UPON RECEIPT, (B)(4) WILL VISUALLY INSPECT A STATISTICAL SAMPLE FOR COMPLIANCE TO THE NEW PROCESSES AND FOR ANY POTENTIAL SHIPPING DAMAGE. (B)(4) WILL DISSEMINATE ACCEPTED NEW CARRY BARS TO THE APPROPRIATE CUSTOMERS AND COLLECT AN EQUAL NUMBER OF OLD (INTERNAL BAR-END WELDS) CARRY BARS. (B)(4) WILL QUARANTINE AND STORE COLLECTED OLD CARRY BARS UNTIL THE REPLACEMENT PROGRAM IS COMPLETED. AT THAT TIME THE OLD CARRY BARS WILL BE RETURNED TO HC FOR FINAL DISPOSITION. A SIMILAR PROCESS OF REPLACEMENT AND QUARANTINE WILL BE CONDUCTED BY HC FOR ALL UNITS DISTRIBUTED THROUGHOUT (B)(4). THE ENTIRE WORLD-WIDE REPLACEMENT PROCESS IS EXPECTED TO BE COMPLETED WITHIN A 4 MONTH TIMEFRAME.

    Description of Event or Problem · 1

    THE BAR-END BROKE OFF FROM A (B)(6) CAPACITY CARRY BAR USED FOR TRANSFERRING PATIENTS BY MEANS OF A HUMAN CARE SINGEL 5100 SATELLIT CEILING TRACK LIFT (CTL). NO PT WAS INVOLVED AND NO INJURIES WERE SUSTAINED. ROOT CAUSE ANALYSIS REVEALED A FAULTY INTERNAL WELD ON THE BAR-END. SINCE THE BAR-END WELDS ARE NOT VISIBLE UPON INSPECTION, HUMAN CARE WILL REPLACE ALL EXISTING CARRY BARS MANUFACTURED PRIOR TO (B)(6) 2009. THE CAPA TO ELIMINATE THIS CONDITION AND PREVENT FUTURE RECURRENCE IS TO EXTERNALLY WELD THE BAR-ENDS, VISUALLY INSPECT EACH WELD, AND PERFORM A DYNAMIC LOAD TEST ON EACH COMPLETE UNIT TO 115% OF MAXIMUM LOAD CAPACITY. THE ABOVE ACTIONS WERE IMPLANTED ON (B)(6) 2009. NOTE: HUMAN CARE BELIEVES THE RISK OF RECURRENCE IS LOW FOR UNITS CURRENTLY INSTALLED BECAUSE: UNITS MANUFACTURED PRIOR TO (B)(6) 2009 RECEIVED A DYNAMIC LOAD TEST TO 100% OF MAXIMUM CAPACITY. ALL NON-INSTALLED UNITS HAVE BEEN SUCCESSFULLY QUARANTINED EITHER AT THE MANUFACTURING LOCATION IN (B)(4) OR AT (B)(4). ONE OCCURRENCE IN 471 UNITS FOR A SUCCESS RATE OF 99.79% (470/471 = .9979 OR 1/471 = .0021).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGEL 5100 SATELLIT CEILING LIFT FNG HUMAN CARE HC SWEDEN AB SATELLIT

    Patients

    Seq Age Sex Outcome Treatment
    1