BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 17780381 · Received September 20, 2023

    Report

    Report Number
    2518422-2023-23790
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 7, 2023
    Report Date
    April 1, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED: 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 RECEIVED INFORMATION ALLEGING "BURNT HUMIDIFIER-BASED CABLE" LOCATED ON THE DEVICE DURING THE DISASSEMBLY PROCESS. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE DEVICE'S ERROR LOG WAS REVIEWED, AND NO ERROR CODES WERE LOGGED. THE DEVICE FAILED THE DECONTAMINATION. DURING DISASSEMBLY, THE FOLLOWING UNIT WAS IDENTIFIED WITH A DEFECTIVE PART AS PER DOCUMENT FC (B)(4) , APPENDIX A, AFFECTED P/N: (B)(6) HUMIDIFIER. SERVICE EVALUATION: ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. DEVICE DISPOSITIONED PER FC (B)(4) . THE DEVICE WAS REWORKED AND PASSED AND WILL BE SENT TO PIL FOR FURTHER INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. CORRECTION TO SECTION B5: THE MANUFACTURER RECEIVED INFORMATION ALLEGING A REMSTAR AUTO A-FLEX HAD A BURNT HUMIDIFIER BASE CABLE (THERMAL EVENT) THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO CUSTOMER COMPLAINT OF PARTICLES OR CONFIRMED FINDINGS OF PARTICLES DURING THE INITIAL EVALUATION OF THE DEVICE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED: 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 RECEIVED INFORMATION ALLEGING "BURNT HUMIDIFIER-BASED CABLE" LOCATED ON THE DEVICE DURING THE DISASSEMBLY PROCESS. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE DEVICE'S ERROR LOG WAS REVIEWED, AND NO ERROR CODES WERE LOGGED. THE DEVICE FAILED THE DECONTAMINATION. DURING DISASSEMBLY, THE FOLLOWING UNIT WAS IDENTIFIED WITH A DEFECTIVE PART AS PER DOCUMENT (B)(4), APPENDIX A, AFFECTED P/N: 1099563 HUMIDIFIERS. SERVICE EVALUATION: ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. DEVICE DISPOSITIONED PER (B)(4), THE DEVICE WAS REWORKED AND PASSED AND WILL BE SENT TO PIL FOR FURTHER INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. CORRECTION TO SECTION B5: THE MANUFACTURER RECEIVED INFORMATION ALLEGING A REMSTAR AUTO A-FLEX HAD A BURNT HUMIDIFIER BASE CABLE (THERMAL EVENT) THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO CUSTOMER COMPLAINT OF PARTICLES OR CONFIRMED FINDINGS OF PARTICLES DURING THE INITIAL EVALUATION OF THE DEVICE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. NEW INFORMATION: THE DEVICE WAS RETURNED TO THE MANUFACTURER AND DURING THE INVESTIGATION EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION WAS NOT OBSERVED IN THIS DEVICE. THE FOAM WAS INTACT AND HAD SIGNIFICANT DUST LIKE CONTAMINATION ON TOP OF IT. AIR FLOW WAS VERIFIED BY THE TECHNICIAN. HIGH PITCH BLOWER WHINE WAS OBSERVED. THE HUMIDIFIER WAS NOT RETURNED WITH THIS DEVICE, BUT A GOOD, HEATED TUBE WAS USED FOR TESTING, AND IT WAS VERIFIED THAT THE TUBE DID HEAT. DURING EXTERNAL AND INTERNAL INSPECTION, THE TECHNICIAN OBSERVED: THE AIR OUTLET PORT HAD WHITE DUST LIKE CONTAMINATION, POTENTIAL MINERAL DEPOSITS INDICATING POSSIBLE WATER INGRESS. THE AIR INLET FILTER WAS MISSING, AND THE AIR INLET WAS CONFIRMED TO HAVE TAN DUST LIKE CONTAMINATION IN IT. THERE WAS DUST LIKE CONTAMINATION CONFIRMED ON THE PCA, BLOWER BOX LID AND SURROUNDING AREA, ON TOP OF THE BLOWER BOX MOTOR INDICATING WATER INGRESS AND ON THE BOTTOM ENCLOSURE. THE AIR INLET SEAL HAD YELLOW AND DUST LIKE CONTAMINATION ON IT. IT WAS SUGGESTED THAT THE SOURCE OF CONTAMINATION WAS MOST LIKELY EXTERNAL TO THE DEVICE. THE TECHNICIAN WAS ABLE TO CONFIRM A THERMAL EVENT ON THE HUMIDIFIER HARNESS CONNECTOR AND PCA AT J9. CARE ORCHESTRATOR INFORMATION WAS RETRIEVED FROM THE DEVICE. ERROR CODES WERE NOT FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG.

    Description of Event or Problem · 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 RECEIVED INFORMATION ALLEGING "BURNT HUMIDIFIER-BASED CABLE" LOCATED ON THE DEVICE DURING THE DISASSEMBLY PROCESS. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE DEVICE'S ERROR LOG WAS REVIEWED, AND NO ERROR CODES WERE LOGGED. THE DEVICE FAILED THE DECONTAMINATION. DURING DISASSEMBLY, THE FOLLOWING UNIT WAS IDENTIFIED WITH A DEFECTIVE PART AS PER DOCUMENT (B)(4), APPENDIX A, AFFECTED P/N: 1099563 HUMIDIFIER. SERVICE EVALUATION: ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. DEVICE DISPOSITIONED PER (B)(4). THE DEVICE WAS REWORKED AND PASSED AND WILL BE SENT TO PIL FOR FURTHER INVESTIGATION. 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
    1590077 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN561S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown