BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 14289035 · Received May 5, 2022

    Report

    Report Number
    1220908-2022-01567
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017163
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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

    THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE. THE REPORTED EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 1220908-2022-01092. THIS REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTIONS D4: SERIAL NUMBER AND H4: DEVICE MANUFACTURE DATE. EVALUATION RESULTS: THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE ECG DATA FROM THE EVENT WAS RETURNED AND EVALUATED. REVIEW OF THE DATA FOUND THAT THE QRS SYNC MARKER DETECTION WAS SENSED WITHIN THE QRS COMPLEX. THE QRS DETECTION SIGNAL IS FILTERED BY A SPECIAL BAND PASS FILTER TUNED TO HAVE IT'S GREATEST AMPLITUDE OUTPUT OR ENERGY BASED ON A TYPICAL QRS SIGNAL FREQUENCY. THIS DETECTION SIGNAL IS DELAYED SLIGHTLY FROM REAL-TIME INPUT. THE DETECTION HELPS REDUCE FALSE DETECTIONS ON TYPICAL QRS COMPLEXES. HOWEVER, WITH ABNORMAL COMPLEX MORPHOLOGY, LOW QR AMPLITUDE, OR WIDE QRS WIDTH, MOST OF THE QRS ENERGY IS SHIFTED TO THE RS TIME AND THE SYNC MAY OCCUR IN THIS TIME OF THE QRS SEGMENT. THE DATA INDICATES THAT THIS IS OCCURRING IN THE PATIENT FOR THIS CASE. BASED ON OUR REVIEW OF THE DATA WE HAVE CONCLUDED THAT THE LOG SHOWED NO INDICATION THAT SYNCHRONIZED CARDIOVERSION WAS AFFECTED BY AN INTERNAL PACEMAKER. 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 CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD NOT CONVERT THE PATIENT'S HEART RHYTHM. 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
    1143716 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA 00847946017163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown