BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRONICS REMSTAR PRO

    MDR report key: 12301450 · Received August 9, 2021

    Report

    Report Number
    MW5103114
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    June 22, 2021
    Report Date
    August 5, 2021
    Manufacturer
    PHILIPS HEALTHCARE / RESPIRONICS, INC.
    Product Code
    BZD
    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 HAVE BEEN USING A PHILIPS REMSTAR PRO SINCE (B)(6) 2014 AND EXPERIENCED BREATHING PROBLEMS, STOPPED USING THE ITEM ON THE ABOVE DATE AND MY BREATHING PROBLEMS ARE BETTER NOW. THERE IS BLACK MATERIAL INSIDE THE BREATHING TUBE WHERE IT CONNECTS TO THE MACHINE. I HAVE NOT BEEN ABLE TO FIND A LAB THAT WILL TEST FOR THE POLYESTER BASED POLYURETHANE FOAM USED IN THE PRODUCT THAT WAS THE REASON FOR THE RECALL ON THE DEVICE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191378 PHILIPS RESPIRONICS REMSTAR PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS HEALTHCARE / RESPIRONICS, INC. REMSTAR PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR