BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROLINE CPAP DEVICE

    MDR report key: 19192493 · Received April 25, 2024

    Report

    Report Number
    MW5154336
    Event Type
    Other
    Date Received
    April 25, 2024
    Date of Event
    January 1, 2008
    Report Date
    April 25, 2024
    Manufacturer
    UNK
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO SUBMIT A REPORT ABOUT HER HERSELF AND HER HUSBAND'S ADVERSE EFFECTS THEY HAVE EXPERIENCED USING CPAP MACHINE. SHE SAID THEY HAVE BEEN USING THE CPAP DEVICE SINCE 2008. SHE SAID THEY HAVE A CAR ACCIDENT IN 2017 AND WENT TO THE EMERGENCY ROOM. SHE SAID WHEN SHE HAS AN X-RAY PERFORMED TO DETERMINE IF SHE HAS BROKEN BONES, THEY FOUND THAT SHE HAD NODULES IN HER LUNGS. SHE WAS TOLD TO FOLLOW UP WITH HER PRIMARY DOCTOR AND SHE DID. SHE SAID HER DOCTOR TOLD HER THAT THE NODULES ARE SMALL, BUT THEY TOLD HER THAT THEY WILL WATCH IT. SHE SAID SHE HAS USED 3 DIFFERENT DEVICES FROM 2008 TO PRESENT. HER FIRST DEVICE WAS CHANGED TO PRO-LINE CPAP ON (B)(6) 2022. THEN THAT MACHINE HAS BEEN RECALLED AND SHE WAS GIVEN AN INTERIM DEVICE ON (B)(6) 2023. THAT DEVICE HAS BEEN RECALLED AND REPLACED WITH THE ONE SHE CURRENTLY USES. SHE SAID SHE IS HAPPY WITH THE ONE SHE HAS RIGHT NOW, BUT SHE IS NOT USING IT OFTEN BECAUSE OF ALL THE COMPLAINTS SHE HEARS OUT THERE. REF REPORT: MW5154335, MW5154337.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980954 PROLINE CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female