BEUDAMED
    FDA Adverse Event Death Summary report: N

    1220908-2017-01009

    MDR report key: 6531022 · Received April 28, 2017

    Report

    Report Number
    1220908-2017-01009
    Event Type
    Death
    Date Received
    April 28, 2017
    Report Date
    April 19, 2017
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS CORRECTING INFORMATION SUBMITTED ON FOLLOW UP MEDWATCH REPORT 01. PLEASE SEE BELOW: THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. A REVIEW OF THE DEVICE'S ACTIVITY LOG CONFIRMED THE CUSTOMER'S REPORT. HOWEVER, THERE WAS NO EVIDENCE OF A PRODUCT PROBLEM. THE CUSTOMER HAD BEEN VIEWING ECG IN LEAD II AND HAD DEFIBRILLATION ELECTRODES ATTACHED. WHEN THIS OCCURS, THE USER HAS TO SWITCH "VIEWS" MANUALLY TO PADS UNLESS A DEFIB FUNCTION (CHARGE, ANALYZE, +/- ENERGY) IS PERFORMED IN WHICH THE DEVICE WILL AUTOMATICALLY DEFAULT TO PADS VIEW. THE REVIEW OF THE LOG SHOWED A VALID IMPENDENCE FROM THE PATIENT; HOWEVER THE USER DID NOT SWITCH TO PADS VIEW. THE DEVICE PUT THROUGH PERFORMANCE AND FUNCTIONAL TESTING AND OPERATED TO SPECIFICATIONS. DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. A REVIEW OF THE DEVICE'S ACTIVITY LOG CONFIRMED THE CUSTOMER'S REPORT. HOWEVER, THERE WAS NO EVIDENCE OF A PRODUCT PROBLEM. THE CUSTOMER HAD BEEN VIEWING ECG IN LEAD II AND HAD DEFIBRILLATION ELECTRODES ATTACHED. WHEN THIS OCCURS, THE USER HAS TO SWITCH "VIEWS" MANUALLY TO PADS UNLESS A DEFIB FUNCTION (CHARGE, ANALYZE, +/- ENERGY) IS PERFORMED IN WHICH THE DEVICE WILL AUTOMATICALLY DEFAULT TO PADS VIEW. THE REVIEW OF THE LOG SHOWED THAT THE ECG WAVEFORM WAS OBTAINED AS THERE WAS A VALID IMPENDENCE FROM THE PATIENT; HOWEVER THE USER DID NOT SWITCH TO THE CORRECT MODE IN ORDER TO VIEW IT ON THE DISPLAY. THE DEVICE PUT THROUGH PERFORMANCE AND FUNCTIONAL TESTING AND OPERATED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A TRANSPORT, WHILE PERFORMING CPR ON A PATIENT (AGE & GENDER UNKNOWN) IN CARDIAC ARREST, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODES TO CONTINUE TREATING THE PATIENT; BUT UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death