BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 17778514 · Received September 20, 2023

    Report

    Report Number
    2518422-2023-23762
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 7, 2023
    Report Date
    January 30, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT: DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    1) THE DEVICE WAS RECEIVED BY THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY. THE DEVICE HAS BEEN EVALUATED FOR LAB INVESTIGATION. DURING THE EXTERNAL AND INTERNAL EVALUATION OF THE DEVICE, IT IS OBSERVED THAT THERE IS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN IN THE DEVICE. THIS INVESTIGATION WAS PERFORMED AS OUTLINED IN ER 2244873 (V01). BECAUSE THE DEVICE RETURNED FROM SERVICE MISSING THE SENSOR SEAL, PIL HAD TO REASSEMBLE THE DEVICE WITH PIL SUPPLIED PARTS TO VERIFY OPERATION. THE ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. PIL USED A KNOWN GOOD PIL SUPPLIED HUMIDIFIER (ETF 3100682-021) ON BASE DEVICE AND VERIFIED THE HEATER PLATE DID NOT HEAT. PIL USED A PIL SUPPLIED KNOWN GOOD HEATED TUBE ON THE KNOWN GOOD PIL SUPPLIED HUMIDIFIER (ETF 3100682-021) AND VERIFIED TUBE DID NOT HEAT. HUMIDIFICATION INOPERATIVE POSSIBLY BECAUSE OF THE J9 THERMAL EVENT INV0636. PIL ALSO OBSERVED THE FOLLOWING FROM AN EXTERNAL AND INTERNAL INSPECTION: AIR INLET FILTER MISSING. UI (USER INTERFACE) KNOB BROKEN. THE AIR OUTLET PORT HAD TAN DUST-LIKE CONTAMINATION IN IT. POTENTIAL MINERAL DEPOSITS IN OUTLET PORT INDICATE POSSIBLE WATER INGRESS. AIR INLET HAD TAN DUST-LIKE CONTAMINATION IN IT. PCA (PRINTED CIRCUIT ASSEMBLY) HAD DUST-LIKE CONTAMINATION ALL OVER THE TOP OF IT. ADDITIONALLY, DUST-LIKE CONTAMINATION FOUND ON THE TOP OF THE BLOWER BOX LID AND SURROUNDING AREA, ON THE TOP OF THE BLOWER MOTOR AND INSIDE OF THE BLOWER BOX. POTENTIAL MINERAL DEPOSITS IN BLOWER BOX AND BLOWER MOTOR FOUND WHICH INDICATE POSSIBLE WATER INGRESS. BOTTOM ENCLOSURE HAD DUST-LIKE CONTAMINATION IN IT. THE SOUND ABATEMENT FOAM WAS INTACT AND HAD SIGNIFICANT DUST-LIKE CONTAMINATION ON TOP OF IT. 2) IN THE PREVIOUS FILE THE REPORT WAS SUBMITTED FOR INITIAL WHICH IS UPDATED TO FINAL IN THIS REPORT. ADDITIONALLY, EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID AND CONCLUSION CODE GRID WERE ALSO UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "BURNT HUMIDIFIER-BASED CABLE" LOCATED ON THE DEVICE DURING THE DISASSEMBLY PROCESS. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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
    1615285 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN561S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown