BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER

    MDR report key: 12388718 · Received August 30, 2021

    Report

    Report Number
    2518422-2021-03368
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 15, 2021
    Manufacturer
    RESPIRONICS INC
    Product Code
    BZD
    UDI-DI
    00606959030503
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058. CORRECTED DATA: D8: WAS THIS DEVICE SERVICED BY A THIRD PARTY?: PREVIOUSLY REPORTED AS NO; UPDATED TO UNKNOWN. G4: PMA/510(K) NUMBER: PREVIOUSLY REPORTED AS K113068; UPDATED TO K131982.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO DEVELOP CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF A MEDICATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283299 REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC DE562S 00606959030503

    Patients

    Seq Age Sex Outcome Treatment
    1 Other