BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTO

    MDR report key: 14654830 · Received June 10, 2022

    Report

    Report Number
    2518422-2022-06049
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    February 17, 2015
    Report Date
    May 3, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959031470
    PMA / PMN Number
    K050759
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF COMPLAINTS THAT WERE REASSESSED AS REPORTABLE FOAM DEGRADATION COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING THE PARTICLES IN AIR PATH. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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. SECTION H6 UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THIS DEVICE ON MDR 2518422-2022-06049-1. PLEASE DISREGARD MDR 2518422-2022-06049-1 AS IT WAS FILED IN ERROR.

    Description of Event or Problem · 0

    A BIPAP DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. DURING THE EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, THE FOAM WAS REPLACED DUE TO PREVENTATIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725558 BIPAP AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 760P 00606959031470

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown