BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX W/SD CARD, GER

    MDR report key: 12279664 · Received August 5, 2021

    Report

    Report Number
    2518422-2021-02795
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 26, 2021
    Report Date
    July 12, 2023
    Manufacturer
    RESPIRONICS INC
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED PARTICLES IN THE DEVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO AN AUTHORIZED SERVICE CENTER FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED. THE SERVICE CENTER FOUND EVIDENCE OF DUST/DIRT CONTAMINATION. THE DEVICE PASSED ALL FINAL TESTING. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND E-55, E-53 AND E-65 ON THE ERROR LOG. THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE DEVICE HAS BEEN SCRAPPED BASED ON CUSTOMER'S REQUEST.

    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: B3 DATE OF EVENT: PREVIOUSLY REPORTED AS (B)(6) 2021 ; 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 AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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
    1178162 REMSTAR AUTO A-FLEX W/SD CARD, GER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC DE552S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown