BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 9560311 · Received January 7, 2020

    Report

    Report Number
    1220908-2019-04110
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Report Date
    December 17, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017163
    PMA / PMN Number
    K060559/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE ACTIVITY LOGS SHOWED THAT THE DEVICE FAILED THE AUTOMATIC READINESS TESTING DUE TO HAVING THE ONESTEP BASE PEDIATRIC PADS ATTACHED WHEN THE CONFIGURATION OF THE DEVICE WAS SET FOR CPR/MWP/COMPLETE PADS TO BE USED FOR THE AUTOMATIC READINESS TESTING. THE CONFIGURATION FOR THE AUTOMATIC READINESS TEST WAS UPDATED TO ONESTEP BASE ADULT WHICH WILL WORK WITH ANY SELF TEST SET UP. THIS IS NOT A DEVICE MALFUNCTION AND THIS REPORT HAS BEEN CLOSED AS DEVICE MEETS SPECIFICATION. REPORTS OF THIS NATURE ARE NOT CONSIDERED TO MEET OUR REQUIREMENTS FOR SUBMISSION OF A MEDWATCH REPORT DUE TO NO POTENTIAL FOR CLINICAL IMPACT. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB PAD SHORT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20639 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA 00847946017163

    Patients

    Seq Age Sex Outcome Treatment
    1