BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTON DEAN MEDICAL

    MDR report key: 59549 · Received December 24, 1996

    Report

    Report Number
    1720804-1996-00004
    Event Type
    Malfunction
    Date Received
    December 24, 1996
    Date of Event
    September 25, 1996
    Report Date
    December 24, 1996
    Manufacturer
    ALTON DEAN MEDICAL, INC.
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PRESSURE INFUSOR DOOR/COVER CRACKED UNDER PRESSURE AT THE HINGE & "EXPLODED OFF FROM THE REST OF THE UNIT. NO CUSTOMER COMPLAINT WAS FILED AND NO ONE WAS INJURED. UNIT (1 OF 2) WAS DISCOVERED DURING ROUTINE EVALUATION OF RETURNED UNITS FROM FACILITY, BY CO REPAIR TECH. UNIT HAD A SEPARATED DOOR AND A NOTE TAPED ON IT THAT THE DOOR "EXPLODED" OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTON DEAN MEDICAL PRESSURE INFUSOR KZD ALTON DEAN MEDICAL, INC. AD-500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other