BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PRO CFLEX

    MDR report key: 12355784 · Received August 23, 2021

    Report

    Report Number
    2518422-2021-03421
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    December 28, 2018
    Report Date
    August 29, 2023
    Manufacturer
    RESPIRONICS INC
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED A VOLUNTARY MEDWATCH REPORT (MW 5102218) IN WHICH AN END USER ALLEGED THEIR CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED LYMPHOMA IN (B)(6) 2019. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF IMMUNOCHEMOTHERAPY. THERE IS NO PATIENT CONTACT INFORMATION NOR SERIAL NUMBER OF DEVICES AVAILABLE FROM THE MEDWATCH REPORT. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH REPORT (MW5102218) IN WHICH AN END USER ALLEGED THEIR CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED LYMPHOMA IN 2019. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF IMMUNOCHEMOTHERAPY. THERE IS NO PATIENT CONTACT INFORMATION NOR SERIAL NUMBER OF DEVICES AVAILABLE FROM THE MEDWATCH REPORT. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252158 REMSTAR PRO CFLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC 461P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O