BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAM STATION AUTO CPAP HUM HT CELL DOM

    MDR report key: 12059169 · Received June 23, 2021

    Report

    Report Number
    MW5102119
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 22, 2021
    Manufacturer
    PHILIPS / RESPIRONICS INC
    Product Code
    BZD
    UDI-DI
    00606959022652
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I INSERTED A LONG METAL BOBBY PIN INTO MY HAIR AND USED THE MACHINE. BEFORE I FELL ASLEEP, I FELT A JOLT OF ELECTRICITY SEEMINGLY TO COME FROM MY HEART THROUGH MY RIGHT BREAST AND THROUGH THE NIPPLE. MY AT HOME EKG SHOWED WILD ACTIVITY. EVEN THOUGH I HAVE AFIB, THE ELECTRICAL SIGNALS WERE NEVER THAT WILD. I WAS SORE FOR ABOUT A WEEK, AND THE SYMPTOMS ALL WENT AWAY FINALLY . I REPORTED THIS TO THE HEALTHLINE OFFICE WHERE I GOT THE MACHINE, AS WELL AS TO MY CARDIOLOGIST. I HAVE NOT SLEPT WITH ANY PINS OR ANYTHING ELSE IN MY HAIR SINCE. NO FURTHER PROBLEMS OF THAT NATURE TO REPORT. I UNDERSTAND THERE IS A RECALL IN EFFECT, AND I HAVE STOPPED USING THE MACHINE. I AM HOPING TO GET ANOTHER MACHINE NOT AFFECTED BY THE RECALL. I BELIEVE THE RECALL INVOLVES FOAM MATERIAL? THANK YOU. (B)(6). THE MACHINE IS UNDER RECALL, AND THE INFORMATION IS AS FOLLOWS; PHILIPS RESPIRONICS DREAM STATION AUTO CPAP HUM HT CELL DOM. REFERENCE # DSX 500 TIIC, WITH DREAM STATION HUM CORE, PACK DOM, REFERENCE #DSXHCP. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944142 DREAM STATION AUTO CPAP HUM HT CELL DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS INC DREAM STATION AUTO CPAP HUMHTCEL DATE ON MACHINE-2021/03/04 00606959022652

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other