BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL-LIFE-VEST

    MDR report key: 8273958 · Received January 23, 2019

    Report

    Report Number
    MW5083311
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    November 12, 2018
    Report Date
    January 19, 2019
    Manufacturer
    ZOLL MANUFACTURING CORP.
    Product Code
    MVK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DATE AS CLOSE AS POSSIBLE, I WAS WEARING VEST AND SOMETHING HAPPENED WITH MY BREATHING AND IT STARTED MAKING A STRANGE SOUND, THIS WENT ON FOR A FEW MINS AND THEN I HAD TROUBLE STANDING AND I CAN ONLY WALK IN THE CIRCLE, AND MY SPEECH "MONTHLY" AND MY FACE STARTED DRIPPING. I DEVELOPED A HEADACHE SO BAD I CAN BARELY SEE, I THOUGHT I WAS HAVING A STROKE. I CALLED NINE-ONE-ONE AND ENDED UP IN THE HOSP WHERE I STAYED FOR I BELIEVE IT WAS ALMOST 3 WEEKS, AND THE DATA MYSTERIOUSLY DISAPPEARED FOR THAT TIME FRAME FROM ZOLL. I WAS GOING TO THE BATTERY OF TESTS AND WAS TOLD THAT I DID NOT HAVE A STROKE. I DID NOT HAVE A HEART ATTACK AND THEY'RE NOT EVEN SURE IF I EVEN HAD A SEIZURE. THE DEVICE WAS REPLACED AND I WAS GIVEN A NEW ONE AND THE SPECIFIC ONE DEVICE, I'M FINDING MYSELF CONTACTING CUSTOMER SERVICE REGULARLY BECAUSE IT'S NOT UPLOADING DATA PROPERLY. I'M HAVING TO CONTINUOUSLY ANSWER THE SAME QUESTIONS EXPLAIN TO THEM THE SERIAL NUMBERS OF ALL THE EQUIPMENT THAT I HAVE OVER AND OVER. I ALSO WONDERED FOR THE PRICE IF THEY'RE TRACKING US ALLEGEDLY SHOULD MAKE IT AS SOME TYPE OF THE TELEPHONE THAT WE CAN HAVE YOU CAN'T EVEN CALL 911, AND IT DOESN'T LET ANYONE KNOW WHERE WE'RE AT WHEN IT HAPPENS EVEN LIFE ALERT IS A TINY DEVICE AND CAN DO THAT SO;I OFTEN FEEL LOST IN THE MIDDLE OF NOWHERE IF SOMETHING DID HAPPEN, I'M EVEN WORSE OFF THAN I WAS IF I DIDN'T WEAR IT. I'M AWESOME BRUISED BECAUSE HE HITS ME AND PARTS OF MY BODY. I BECOME SHADOW TO MY CAR SEAT BELTS, SHOPPING CARTS, AND ALL TYPES OF THINGS WHICH IS DANGEROUS BECAUSE I HAVE FALLEN TWICE ALREADY BECAUSE OF IT. I'M NOT SURE IF DEVICE IS DANGEROUS OR HELPFUL THESE DAYS. BECAUSE THEY COULDN'T FIND THE DATA UNFORTUNATELY, I COULDN'T FIND THE HOTSPOT SO I DO STILL POSSESS THAT I'M NOT GIVING IT TO HIM UNTIL I FIND OUT IF IT HAS ANY DATA ON IT THAT CAN HELP FIGURE OUT WHAT HAPPENED IN THAT TIME FRAME, BECAUSE NO ONE KNOWS AND ZOLL CLAIMS THEY HAVE NO DOUBT OF THAT TIME FRAME. ALL THEY DID WAS REPLACED, ADVISE AND TELL ME THEY COULDN'T FIND ANY INFO. I DON'T KNOW IF THEIR HOTSPOT HAS ANY INFO ON IT BUT I STILL HAVE THAT. THEY GAVE ME A NEW ONE BUT I GOT THE OLD ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65445 ZOLL-LIFE-VEST WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization