BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 16409591 · Received February 21, 2023

    Report

    Report Number
    2518422-2023-05314
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    February 6, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING OF A THERMAL EVENT TO A REMSTAR PRO C-FLEX+ POWER SUPPLY. THE USER ALLEGES THE FRAYED POWER SUPPLY CORD WHICH JOINS AT THE POWER BRICK OVERHEATED AND CAUGHT FIRE. THERE WAS NO SMOKE BUT AN ODOR OF ELECTRICAL BURNING WIRE SMELL. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. PATIENT REPORTS DYSPNEA AND A LUNG CT SCAN BUT REFUSES TO GIVE ADDITIONAL INFORMATION. THE DEVICE HAS BEEN RECEIVED BUT THE INVESTIGATION HAS NOT YET BEGUN. CORRECTION - DYSPNEA AND IMAGING WERE REPORTED AND THE PATIENT OUTCOME AND HEALTH IMPACT CODING WAS UPDATED, AND NOW REFLECTS THAT INFORMATION. NO MEDICAL INTERVENTION WAS REPORTED. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. H3 OTHER TEXT : DEVICE RECEIVED, EVALUATION HAS NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THAT WE WERE 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 OF A THERMAL EVENT TO A REMSTAR PRO C-FLEX+ POWER SUPPLY. THE USER ALLEGES THE FRAYED POWER SUPPLY CORD WHICH JOINS AT THE POWER BRICK OVERHEATED AND CAUGHT FIRE. THERE WAS NO SMOKE BUT AN ODOR OF ELECTRICAL BURNING WIRE SMELL. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THE USER LATER REPORTED DYSPNEA AND LUNG IMAGING WAS REPORTED. NO MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED AND INVESTIGATED AT THE PRODUCT INVESTIGATION LAB. NO AC POWER CORD, DC POWER SUPPLY OR FOAM INLET FILTER WERE RETURNED. DEVICE TESTING WAS DONE WITH IN HOUSE, KNOWN GOOD AC POWER CORD AND DC POWER SUPPLY. THE DEVICE POWERED UP WITHOUT ISSUE. AN INDISCRIMINATE ODOR WAS OBSERVED DURING THERAPY. THE INTERNAL AND EXTERNAL INSPECTIONS OBSERVED THE RIGHT PANEL ASSEMBLY AND THE AIR OUTLET PORT HAD DUST-LIKE CONTAMINATION ON THEM AND IN THE AIR OUTLET PORT. THE AIR INLET PORT HAD DUST-LIKE CONTAMINATION IN IT. THE PCA HAS DUST-LIKE CONTAMINATION ALL OVER THE TOP OF IT ESPECIALLY NEAR THE USER INTERFACE KNOB AREA. DUST-LIKE CONTAMINATION ON THE TOP OF THE BLOWER BOX LID AND SURROUNDING AREA. THERE IS DUST-LIKE CONTAMINATION ON THE TOP OF THE BLOWER MOTOR AND INSIDE OF THE BOTTOM ENCLOSURE. THE AIR INLET SEAL HAS YELLOWED AND HAD DUST LIKE CONTAMINATION ON IT. THE SOUND ABATEMENT FOAM WAS INTACT AND HAD DUST-LIKE CONTAMINATION ON THE TOP OF IT. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THIS DEVICE. THERE WAS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE, WHICH SUGGEST THAT THE SOURCE OF THE CONTAMINATION WAS EXTERNAL TO THE DEVICE. THE INVESTIGATION WAS UNABLE TO CONFIRM THE COMPLAINT OF THE DEVICE NOT FUNCTIONING AND UNABLE TO ADDRESS THE SYMPTOMS OF THE POWER CORD/POWER SUPPLY CORD FRAYING, ARCING AND SPARKING IN THE MIDDLE OF THE NIGHT.

    Additional Manufacturer Narrative · 0

    NO PRODUCT RETURNED.

    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 OF A THERMAL EVENT TO A REMSTAR PRO C-FLEX+ POWER SUPPLY. THE USER ALLEGES THE FRAYED POWER SUPPLY CORD WHICH JOINS AT THE POWER BRICK OVERHEATED AND CAUGHT FIRE. THERE WAS NO SMOKE BUT AN ODOR OF ELECTRICAL BURNING WIRE SMELL. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THIS EVENT IS REPORTABLE DUE TO THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AS IDENTIFIED IN CAPA (B)(4). THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THIS EVENT IS REPORTABLE DUE TO THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AS IDENTIFIED IN CAPA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228870 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CA451S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male