BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 16781389 · Received April 20, 2023

    Report

    Report Number
    1220908-2023-01508
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    April 1, 2023
    Report Date
    April 5, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE CLINICAL FILE OF THE CUSTOMER'S REPORT WAS PROVIDED. REVIEW OF THE CLINICAL FILE DID SHOW THE CUSTOMER'S REPORT. SEGMENTS 1 AND 3 WERE DETERMINED TO BE VENTRICULAR FIBRILATION (VF) AND SEGMENT 2 WAS DETERMINED TO BE A NORMAL SINUS RHYTHM (NSR). THE ECG DURING SEGMENTS 1 AND 3 HAD QRS COMPLEXES THAT WERE UNEVENLY SPACED AND HAD VARIANCES IN AMPLITUDE BOTH POSITIVELY AND NEGATIVELY DEFLECTING. THE UNEVEN SPACING AND AMPLITUDE VARIANCES CAUSED THE WAVEFORM MEASUREMENTS TO MATCH PREDEFINED VALUES FOR VF. THE INVESTIGATION CONCLUDED THE DEVICE OPERATED AS EXPECTED WITHIN THE LIMITATIONS OF THE TECHNOLOGY. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVE WAS NON-SHOCKABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461353 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown