BEUDAMED
    FDA Adverse Event Death Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 5022154 · Received August 17, 2015

    Report

    Report Number
    1220908-2015-02049
    Event Type
    Death
    Date Received
    August 17, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946011420
    PMA / PMN Number
    K042007
    Adverse Event
    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 FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S DEVICE WAS RETURNED FOR A REPORT THAT THE DEVICE DISPLAYED A "DEFIB FAULT 77" MESSAGE AND EITHER SHUT DOWN, OR THE DISPLAY BLANKED OUT. THE CUSTOMER ALSO REPORTED THAT THE DEVICE WAS SUBSEQUENTLY UNABLE TO TURN ON. OUR REVIEW OF THE DEVICE'S ACTIVITY LOGS DID NOT FIND ANY EVIDENCE TO SUPPORT THE CUSTOMER'S REPORT THAT A "DEFIB FAULT 77" MESSAGE WAS DISPLAYED AT ANY TIME. THE CUSTOMER STATED THEY WERE CONFIDENT THAT THIS DEVICE WAS THE DEVICE IN THE PATIENT EVENT. HOWEVER, WE DID ASK THE CUSTOMER TO VIEW THE ACTIVITY LOGS FOR THE FIVE DEVICES THEY HAVE AT THEIR FACILITY, AND THE MESSAGE WAS NOT FOUND IN THE ACTIVITY LOGS. OUR INVESTIGATION FOR THIS REPORTED MALFUNCTION WAS UNSUBSTANTIATED. THE CUSTOMER'S REPORT THAT THE DEVICE EITHER SHUT OFF, OR THE DISPLAY BLANKED OUT WAS NOT REPLICATED AFTER EXTENSIVE TESTING. THE DEVICE PASSED THE FINAL TEST PROCEDURE WITH NO FAULTS FOUND. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN) THE DEVICE DISPLAYED A "DEFIB FAULT 77" MESSAGE AND THEN EITHER THE DISPLAY BLANKED OUT, OR THE DEVICE SHUT OFF. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. COMPLAINANT INDICATED THAT DURING SUBSEQUENT TESTING, THE DEVICE WAS INTERMITTENTLY UNABLE TO POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543703 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA 00847946011420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death