BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRONICS REMSTAR

    MDR report key: 15925126 · Received December 5, 2022

    Report

    Report Number
    MW5113644
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    June 30, 2021
    Report Date
    December 1, 2022
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PHILIPS RESPIRONICS HAS MY REMSTAR IS NOTIFIED NOT TO USE MY RESPIRONIC SINCE (B)(6) 2021 (18 MONTHS AGO). I SUBMITTED FROM MY DOCTOR'S PRESCRIPTION TO PHILIPS ON (B)(6) 2022. PHILIP SENT ME A LETTER STATED THEY WILL SHIP LESS THAN 30 DAYS FROM RECEIPT OF MY PRESCRIPTION. NOTHING FROM PHILIPS. IN 18 MONTHS SINCE I WAS NOTIFIED TO STOP USING THIS DEVICE AND ONLY RECEIVED 3 STATUS FROM PHILIPS. I HAVE BEEN TOO PT WITH UNABLE TO USE MY CPAP 18 MONTHS AND NO/POOR INFORMATION FROM PHILIPS; 18 MONTHS IS TOO LONG NOT USING A NECESSARY CPAP USAGE - THIS COULD LEAD TO DEATH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239370 PHILIPS RESPIRONICS REMSTAR VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. REMSTAR RESPIRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Disability MULTI-VITAMINS