BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 12973418 · Received December 9, 2021

    Report

    Report Number
    2031642-2021-05732
    Event Type
    Death
    Date Received
    December 9, 2021
    Date of Event
    February 10, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO ABSENCE OF INFORMATION REGARDING DEVICE SERIAL NUMBER AND INSTITUTION OF CLINICAL USE, FURTHER INVESTIGATION INTO DEVICE EVALUATION, RESOLUTION, CONCLUSION AND ROOT CAUSE CANNOT BE FURTHER CONDUCTED. A COMPLAINT RECORD OF THE ALLEGATION AND EVENT SHALL BE CATALOGED WITHIN PHILIPS COMPLAINT HANDLING DATABASE. SHOULD FURTHER INFORMATION BE PROVIDED AT A FUTURE DATE, THE COMPLAINT RECORD SHALL BE AMENDED WITH APPROPRIATE FOLLOW-UP REPORTING TO COMPETENT AUTHORITIES CONDUCTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED NOTIFICATION OF A VOLUNTARY MEDWATCH REPORT # MW5105082 STATING THAT A PATIENT HAD EXPIRED DURING CLINICAL AND THERAPEUTIC USE OF THE V60 VENTILATOR ON (B)(6)2020. THE DECEDENTS NEXT OF KIN ALLEGES POOR DATA QUALITY TO HAVE CAUSED AND/OR CONTRIBUTED TO THE PATIENT EXPIRATION. BASED UPON THE INFORMATION PROVIDED WITHIN #MW5105082, IT IS UNCLEAR IF THE ALLEGATION IS BEING LODGED AGAINST THE V60 VENTILATOR OR THE TRILOGY 100 VENTILATOR. BASED UPON THE INFORMATION PROVIDED BY THE DECEDENTS NEXT OF KIN, THE PATIENT HAD BEEN RECEIVING THERAPY FOR APPROXIMATELY SIX MONTHS VIA A PHILIPS RESPIRONICS TRILOGY 100. THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND LETHARGY RESULTING IN HOSPITALIZATION. IT WAS NOTED THAT APPROXIMATELY FOUR TO FIVE TIMES OVER AN UNSPECIFIED PERIOD OF TIME THE PATIENT HAD BEEN HOSPITALIZED. PREVIOUS DIAGNOSES INCLUDE: CHRONIC AND ACUTE RESPIRATORY FAILURE WITH HYPOXIA AND HYPERCAPNIA, CONGESTIVE HEART FAILURE, COPD (UNSPECIFIED), CHRONIC HYPERTENSION, ACUTE ENCEPHALOPATHY, AND SEPTIC SHOCK. CONCOMITANT MEDICATIONS HAVE BEEN LISTED AS: BENZONATATE 100 MG, CEFDINIR 300 MG, PREDNISONE 20MG, ALBUTEROL 2.5 MG ,TAMA ESCITALOPR.AM OXALATE 10MG, GABAPENTIN 300 MGS,LISINOPRIL 10- 12.5 MG, ONDANSETRON 10 MGS, UMECLIDINIUM- VILANTEROL 62.5-25 MCG/ACTUATION INHALER. FURTHER INFORMATION REGARDING PATIENT EXPIRATION, CAUSE OF DEATH, AND EVENT CONTEXT HAVE NOT BEEN DIVULGED TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869822 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death