BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK

    MDR report key: 2070382 · Received April 18, 2011

    Report

    Report Number
    1523530-2011-00010
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MIDMARK CORP.
    Product Code
    GBB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STAPLES HOLDING THE VINYL TO THE ARM BOARD WERE TOO LONG AND NOT TO SPECIFICATIONS. THIS ALLOWED PART OF THE STAPLE TO EXIT THE SIDE OF THE ARM BOARD INTO THE FOAM PADDING. OVER TIME, THE VINYL WORE TO THE POINT THAT THE END OF THE STAPLE WAS ABLE TO CONTACT THE PATIENT. THE ARMS WERE REPLACED ON THREE SEPARATE CHAIRS. ONLY 1 OF THE SIX ARMS WAS DEFECTIVE. WE WERE UNABLE TO DETERMINE WHICH SERIAL NUMBER OF CHAIR THE DEFECTIVE ARM WAS FROM. THE SERIAL NUMBERS OF THE THREE CHAIRS ARE: (B)(4), MANUFACTURE DATE: 03/2009, (B)(4), MANUFACTURE DATE: 08/2010, (B)(4), MANUFACTURE DATE: 08/2010.

    Description of Event or Problem · 1

    CUSTOMER HAD A PATIENT COMPLAIN THEY COULD FEEL THE STAPLES WHEN USING THE ARMREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDMARK CHAIR, SURGICAL, AC-POWERED GBB MIDMARK CORP. 647-002

    Patients

    Seq Age Sex Outcome Treatment
    1