BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVER VIEW AED

    MDR report key: 4449630 · Received January 23, 2015

    Report

    Report Number
    3003521780-2015-00002
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    December 20, 2014
    Report Date
    December 24, 2014
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONIC HISTORY FROM THE AED REVEALS A PATIENT WHOSE ECG RHYTHM IS VF. DURING THE 1ST ANALYSIS INTERVAL THERE ARE SIGNIFICANT CPR ARTIFACTS PRESENT CAUSING THE AED TO BE INDETERMINATE AS TO WHETHER OR NOT TO RECOMMEND A SHOCK. AT THE END OF THIS ANALYSIS INTERVAL THERE IS A MARKED DEVIATION OF THE ECG BASELINE CAUSING THE AED TO DECLARE PATIENT MOTION; THIS MAY COINCIDE WITH CESSATION OF CPR. DURING THE 2ND ANALYSIS INTERVAL THE ECG SIGNAL APPEARS FREE FROM ARTIFACTS AND THE AED APPROPRIATELY RECOMMENDS SHOCK, CHARGES, AND A 50J SHOCK WAS DELIVERED. THE SHOCK CONVERTED THE PATIENT FROM VF TO ASYSTOLE. CPR IS THEN ADMINISTERED, DURING WHICH THE PATIENT'S HEART RESUMED A LIFE SUSTAINING RHYTHM. DURING THE 3RD ANALYSIS PERIOD, THE AED ANALYZED THE PATIENT AND APPROPRIATELY DID NOT ADVISE SHOCK. APPROXIMATELY 1 MINUTE INTO THE FOLLOWING CPR PERIOD, IT APPEARS THAT AT LEAST ONE IF NOT BOTH PADS WERE NO LONGER IN CONTACT WITH THE PATIENT OR WERE REMOVED. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE IN THE ELECTRONIC HISTORY. IN THIS CASE, THE AED PERFORMED APPROPRIATELY AS DESIGNED. THE INVESTIGATION IDENTIFIED THAT THE EVENT APPEARS TO BE RELATED TO USER ERROR - THE USER ATTACHED PEDIATRIC PADS TO AN ADULT PATIENT AND ALTHOUGH THIS DOES NOT APPEAR TO HAVE HAD AN EFFECT ON THE PATIENT OUTCOME, THE PATIENT DID NOT RECEIVE THE RECOMMENDED THERAPY AND TE USE OF PEDIATRIC PADS ON AN ADULT PATIENT COULD RESULT IN DEATH OR SERIOUS INJURY. NO OTHER REPORTS OF PEDIATRIC PADS BEING USED ON AN ADULT PATIENT HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT AT A FITNESS FACILITY A MALE PATIENT, BETWEEN THE AGE OF 50 TO 60, WHO WAS ON A TREADMILL, WENT DOWN. THE STAFF GRABBED AN AED AND BROUGHT IT TO THE PATIENT. A MEMBER AT THE GYM ADVISED SHE KNEW ABOUT AEDS (ACTUAL QUALIFICATIONS ARE NOT KNOWN ABOUT THIS INDIVIDUAL) AND TOOK THE LEAD WITH THE RESCUE. SHE PROCEEDED TO APPLY THE SPARE PEDIATRIC PADS TO THE PATIENT'S CHEST. THE AED IS KEPT IN A WALL MOUNT CABINET WITH ADULT AND PEDIATRIC PADS AND THE ADULT PADS ARE NORMALLY ALWAYS ATTACHED TO THE UNIT. SHE DISCONNECTED THE ADULT PADS AND PLUGGED IN THE SPARE PEDIATRIC PADS. THE AED ANALYZED THE PATIENT, CORRECTLY IDENTIFIED A SHOCKABLE RHYTHM AND DELIVERED A SINGLE 50J DEFIBRILLATION SHOCK TO THE PATIENT. IT WAS INITIALLY REPORTED THAT THE PATIENT WAS IN A COMA. IT WAS LATER REPORTED THE PATIENT IS RECOVERING AND IS COMING IN TO THE FACILITY TO THANK THE STAFF FOR SAVING HIS LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55340 REVIVER VIEW AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-C2300EN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization