BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFORMATRAK MASK

    MDR report key: 11012452 · Received December 15, 2020

    Report

    Report Number
    2518422-2020-03042
    Event Type
    Death
    Date Received
    December 15, 2020
    Report Date
    February 25, 2021
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959007581
    PMA / PMN Number
    K002465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS MADE NUMEROUS ATTEMPTS TO CONTACT THE REPORTING FACILITY TO GATHER ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE MASK FOR INVESTIGATION. NO FURTHER INFORMATION HAS BEEN PROVIDED, AND NO PRODUCT HAS BEEN RETURNED. THE PERFORMATRAK FULL FACE MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. LABELING WARNS THE USER "THIS MASK IS NOT SUITABLE FOR PROVIDING LIFE SUPPORT VENTILATION", AND THAT "THIS MASK SHOULD NOT BE USED ON PATIENTS WHO ARE UNCOOPERATIVE, OBTUNDED, UNRESPONSIVE, OR UNABLE TO REMOVE THE MASK." AS NO FURTHER INFORMATION WAS PROVIDED, AND NO PRODUCT RETURNED, THE MANUFACTURER IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY. NOTE ON MDR 2518422-2020-03042-1, WERE BLANK. THIS REPORT IS BEING FILED AS A CORRECTION TO THAT REPORT, WITH THE ADDITIONAL INFORMATION REPORTED ON THIS SUPPLEMENTAL REPORT MDR 2518422-2020-03043-1.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION OF A PATIENT DEATH AS A RESULT OF THE PATIENT CIRCUIT BECOMING DETACHED FROM THE MASK. THERE WAS NO PATIENT INFORMATION PROVIDED, AND NO OTHER DETAILS OF THE ALLEGED EVENT. THE DATE OF THE REPORTED EVENT IS UNKNOWN. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478136 PERFORMATRAK MASK VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1012574 00606959007581

    Patients

    Seq Age Sex Outcome Treatment
    1 Death