BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PRO

    MDR report key: 5338161 · Received December 31, 2015

    Report

    Report Number
    1220908-2015-03365
    Event Type
    Malfunction
    Date Received
    December 31, 2015
    Date of Event
    December 8, 2015
    Report Date
    December 16, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECG DATA FROM THE EVENT WAS RETURNED AND EVALUATED. EVALUATION FOUND THAT DURING THE FIRST SEGMENT OF THE FIRST ANALYSIS EVENT, THE RHYTHM WAS NOT RECOGNIZED DUE TO HIGH AMPLITUDE ARTIFACT. SEGMENTS TWO AND THREE HAD A QRS RATE AS WELL AS A LOW VARIABILITY OF THE QRS WAVEFORM, THEREFORE A "NO SHOCK ADVISED" DETERMINATION WAS RETURNED. THE SECOND ANALYSIS EVENT RECOGNIZED A QRS RATE AS WELL AS LOW VARIABILITY BETWEEN THE QRS WAVEFORMS, WHICH ALSO RETURNED A "NO SHOCK ADVISED" DETERMINATION. THE THIRD ANALYSIS EVENT RECOGNIZED A QRS RATE AS WELL AS A LOW VARIABILTY BETWEEN THE QRS WAVEFORMS AND ONE OF THE THREE SEGMENTS WAS NOT RECOGNIZED DUE TO HIGH AMPLITUDE ARTIFACT (PRIOR TO THIS ANALYSIS, THE PATIENT'S THERAPY CABLE BECAME DISCONNECTED/RECONNECTED WHICH INTRODUCED ARTIFACT INTO THE ANALYSIS). THIS ANALYSIS EVENT ALSO RETURNED A "NO SHOCK ADVISED" DETERMINATION. BASED ON OUR REVIEW OF THE DATA WE HAVE CONCLUDED THAT THE ANALYSIS PROGRAM RESULTS WERE CORRECT FOR THE SPECIFIC ANALYSES IN QUESTION AND THAT THERE WAS NO INDICATION OF A MALFUNCTION WITH THE DEVICE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS 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
    861755 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1