BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVABLE INTERNAL HANDLES

    MDR report key: 314226 · Received January 26, 2001

    Report

    Report Number
    1220908-2001-00145
    Event Type
    Malfunction
    Date Received
    January 26, 2001
    Report Date
    December 8, 2000
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE OPERATING ROOM CLINICIANS WERE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE AND GENDER UNKNOWN), BUT THE DISCHARGE BUTTON ON THE INTERNAL HANDLES WERE DIFFICULT TO DEPRESS. AFTER MUCH EFFORT THE CLINICIANS WERE EVENTUALLY ABLE TO DEPRESS THE DISCHARGE BUTTON. IN ADDITION, THE COMPLAINANT REPORTED THAT THE HANDLES WERE CRACKED. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION. THE INTERNAL HANDLES OPERATOR'S MANUAL, ADVISES THE USER TO "INSPECT THE INTERNAL HANDLE SET FREQUENTLY FOR SIGNS OF DETERIORATION, SUCH AS CRACKS, CRAZING, DAMAGED CABLES, AND DAMAGED SWITCH COVERS. REPLACE IF DETERIORATION IS NOTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3290 AUTOCLAVABLE INTERNAL HANDLES INTERNAL PADDLE LDD ZOLL MEDICAL CORPORATION 80040023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other