BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 5344245 · Received January 5, 2016

    Report

    Report Number
    1220908-2015-03381
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Report Date
    December 17, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: MKJ. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE MALFUNCTION. REVIEW OF THE DEVICE HISTORY LOGS DID NOT FIND EVIDENCE TO SUPPORT THE CUSTOMER'S REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE CLINICAL DATA WAS NOT AVAILABLE FOR REVIEW AS PART OF THE INVESTIGATION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS CONTACTED FOR RETURN OF THE DEVICE OR DATA FILE. THE DEVICE/DATA FILE HAVE NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PAMI PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL AND SUBSEQUENTLY WOULD NOT DISCHARGE VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS AND NO ECG SIGNAL WAS OBTAINED. CLINICIANS THEN OBTAINED ANOTHER DEVICE USING THE SAME SET OF ELECTRODE PADS AND THE DEVICE DELIVERED THE SHOCK TO THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION AND THE PATIENT WAS CONVERTED BACK TO A NORMAL SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3979 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1