BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN BOW FRAME

    MDR report key: 6941704 · Received October 11, 2017

    Report

    Report Number
    1221538-2017-00002
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    June 29, 2017
    Report Date
    June 29, 2017
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE ANALYSIS WAS PERFORMED AND TESTING WAS EXECUTED TO SUPPORT THE INVESTIGATION. TWENTY (25) ¿DEMO¿ UNITS WERE COLLECTED FROM SALES REPS AND RETURNED TO ACTON, MA FOR TESTING. THE UNITS WERE TESTED PER THE REQUIREMENTS OF DESIGN VERIFICATION AND VALIDATION (QS01641 REV 7) AT 1.528 LIVES AT A DISTRUSTED WEIGHT PROFILE UNDER THIS ¿USE CASE¿ (ON A PAD, SIMILAR TO HOW THE BOW FRAME WAS USED WHICH RESULTED IN THE COMPLAINT). AFTER SUBJECTED TO THE LIFE TESTING PART OF THE TEST PROTOCOL, 100% OF THE BOW FRAMES TESTED SHOWED SOME DEGREE OF CRACKING IN THE SAME AREA WHERE THE CRACK OCCURRED SIMILAR TO THE CRACK DOCUMENTED IN THE COMPLAINT. THE ROOT CAUSE WAS DETERMINED TO BE THE DESIGN OF THE PRODUCT ¿ SPECIFICALLY HOW THE BASE IS CONSTRUCTED AND DESIGNED AS IT DOES NOT SUPPORT A SAFE WORKING LOAD (OVER THE EXPECTED LIFE) IN THIS USE CASE (POSITIONED ON A PAD). A FIELD ACTION (Z-0641-2018) WAS INITIATED, 1221538-10/09/2017-002(C), AND IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED AND INVESTIGATION IS UNDERWAY. A FOLLOW-UP REPORT WILL BE SENT UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    DURING SETUP FOR A PROCEDURE, WITH A (B)(6) PATIENT, THE BOW FRAME CRACKED. THE PATIENT WAS NOT HURT. IT SNAPPED SIMPLY WHEN THEY PUT THE PATIENT ON THE FRAME.

    Description of Event or Problem · 1

    DURING SETUP FOR A PROCEDURE, WITH A (B)(6) LB PATIENT, THE BOW FRAME CRACKED. THE PATIENT WAS NOT HURT. IT SNAPPED SIMPLY WHEN THEY PUT THE PATIENT ON THE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719148 ALLEN BOW FRAME BOW FRAME FWZ ALLEN MEDICAL SYSTEMS, INC. A-70801-A4

    Patients

    Seq Age Sex Outcome Treatment
    1