BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO AFLEX

    MDR report key: 12616743 · Received October 12, 2021

    Report

    Report Number
    2518422-2021-05158
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 28, 2021
    Report Date
    January 3, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959039612
    PMA / PMN Number
    K091319
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THIS DEVICE ON MDR 2518422-2021-05158-1. PLEASE DISREGARD MDR 2518422-2021-05158-1 AS IT WAS FILED IN ERROR.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THIS DEVICE ON MDR 2518422-2021-05158-1. PLEASE DISREGARD MDR 2518422-2021-05158-1 AS IT WAS FILED IN ERROR. PREVIOUS REPORT WAS FILED INCORRECTLY. SECTION H11 SHOULD BE REPORTED AS: THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE I RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP. BIPAP. AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REFX) RT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURERS SERVICE CENTER FOR FURTHER EVALUATION THE DEVICE WAS EVALUATED THERE WAS NO MENTION OF VISUAL FINDING TO THE EXTERNAL PART OF THE DEVICE THE INTERNAL ASPECT OF THE DEVICE WAS INSPECTED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WERE 4 ERRORS FOUND. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMERS ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION. SECTION D8, D9, G3, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) WAS CORRECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON NOV 12, 2024 AND SECTION H11 SHOULD BE REPORTED AS THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND PATIENT ALLEGED OF DIFFICULTY SLEEPING. THE PATIENT WAS PRESCRIBED MEDICATION IN RESPONSE TO THE REPORTED EVENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE SECTIONS B1, B2, H1, H6 HAVE BEEN CORRECTED IN THIS REPORT AS FOLLOWS: SECTION B1 WAS CORRECTED TO PRODUCT PROBLEM (ADVERSE EVENT AND PRODUCT PROBLEM WAS CHECKED IN THE PREVIOUS MDR). SECTION B2 WAS CHANGED TO BLANK (PREVIOUSLY IT WAS OTHER SERIOUS). SECTION H1 WAS CHANGED FROM SERIOUS INJURY TO MALFUNCTION. SECTION H6 HEALTH EFFECT - IMPACT CODE WAS CORRECTED.

    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 A PATIENT TO DEVELOP DIFFICULTY SLEEPING. THE PATIENT WAS PRESCRIBED MEDICATION IN RESPONSE TO THE REPORTED EVENT. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511791 REMSTAR AUTO AFLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 557P 00606959039612

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other