BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVABLE INTERNAL HANDLES (MSERIES)

    MDR report key: 2820490 · Received October 4, 2012

    Report

    Report Number
    1220908-2012-02654
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    LDD
    PMA / PMN Number
    K963781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCLAVABLE INTERNAL HANDLES (MSERIES) INTERNAL PADDLE LDD ZOLL MEDICAL CORP. 8011-0501-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA