BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BY PHILIPS RESPRONICS

    MDR report key: 12525572 · Received September 23, 2021

    Report

    Report Number
    MW5104178
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 21, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVE SIGNIFICANT SLEEP APNEA; I RECEIVED A RECALL LETTER FROM PHILIPS RESPRONICS - THEY CONFIRMED MY DEVICE IS RECALLED AND ADVISED NOT TO USE THE DEVICE. THEY DID NOT PROVIDE ME WITH A DATE FOR THE NEW MACHINE. AND THAT THE NEW MACHINE WOULD HAVE TO PASS CLINICAL TRIALS. I VISITED BY DOCTOR ON 9/2 AND HE MADE A PRESCRIPTION FOR ME AND SUBMITTED TO (B)(6) BY FAX. MY DOCTOR ADVISED A NEW MACHINE FROM RESMED - AN ALTERNATIVE PROVIDER. MY DOCTOR WROTE A PRESCRIPTION FOR MACHINE DAMAGED BEYOND REPAIR. I CALLED (B)(6) A WEEK LETTER AND THEY INDICATED THEY DID NOT HAVE THE FAX FROM MY DR. MY SON WENT TO THE DOCTOR AND RECEIVED A PHYSICAL COPY OF THE PRESCRIPTION - AND WE FAXED TO (B)(6). I CALLED (B)(6) TO CONFIRM RECEIPT. (B)(6) CONFIRMED. (B)(6) REP SAID IT WOULD TAKE A FEW DAYS TO PROCESS. I CALLED (B)(6) LAST WEEK TO CONFIRM PROGRESS - AND THEY TOLD ME MY PRESCRIPTION IS IN PROGRESS. NO UPDATE. I CALLED (B)(6) TODAY TO INQUIRE ON STATUS - AND SHE TOLD ME SHE COULD JUST TELL ME ITS IN PROGRESS. I ASKED WHAT IS THE STATUS OF THE PRESCRIPTION - WAS IT FAXED OR NOT? SHE SAID SHE COULD NOT TELL ME. TODAY, I CALLED (B)(6) AND THEY TOLD ME THE PRESCRIPTION WAS NOT FAXED TO THEM BY (B)(6) I WANT TO REGISTER A COMPLAINT ON (B)(6) AS WELL AS MY DR FOR LACK OF FOLLOW-UP FOR A SERIOUS HEALTH CONDITION CALLED SLEEP APNEA. I HAVE BEEN TESTED FOR SA AND HAVE BEEN TOLD MY SA RATE IF VERY HIGH AND I CANNOT SLEEP WITHOUT A MACHINE. THERE ARE COMPLIANCE RULES AROUND THIS TYPE OF CLAIM REPORTING ERROR AND LACK OF URGENCY I WANT A NEW MACHINE FROM RESMED BASED ON MY PRESCRIPTION SUBMITTED TO (B)(6). THANK YOU, (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421130 DREAMSTATION BY PHILIPS RESPRONICS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. J2245118791D9 NH026172

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other