BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 13759998 · Received March 14, 2022

    Report

    Report Number
    2031642-2022-00656
    Event Type
    Death
    Date Received
    March 14, 2022
    Date of Event
    January 24, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER GOOD FAITH EFFORTS WERE MADE TO THE INSTITUTIONAL DIRECTOR OF PATIENT SAFETY TO OBTAIN THE SPECIFICITY OF THE HUMAN WITH NO RESPONSE YIELDED. DUE TO THE ABSENCE OF FURTHER CORRESPONDENCE, THIS CONCLUDES THE INVESTIGATION FOR THIS COMPLAINT AND THEREFORE WILL ADVANCE THIS CASE TO CLOSURE.

    Description of Event or Problem · 0

    THE INSTITUTION'S BIOMEDICAL DEPARTMENT REPORTED THE V60 VENTILATOR WAS DOWN, AND A PATIENT HAD PASSED AWAY. THE CUSTOMER CONFIRMED THAT THE PASSING WAS NOT ASSOCIATED WITH VENTILATOR. AN (B)(6)YEAR-OLD FEMALE PASSED AWAY DURING CLINICAL USE OF A V60 VENTILATOR, WITH BIPAP MASK AS PATIENT INTERFACE. THE DIRECTOR OF PATIENT SAFETY STATED THE VENTILATOR ALARMED AS EXPECTED AND ADEQUATELY. HE CONFIRMED THAT THERE WAS NO ISSUE WITH THE VENTILATOR AND THAT HOSPITAL DID THEIR OWN INVESTIGATION AND DETERMINED THERE WAS HUMAN ERROR. THE NATURE OF THE HUMAN ERROR WAS NOT PROVIDED. HE FURTHER STATED THAT THE HOSPITAL USED PICTURES OF THE EVENT LOG TO CONFIRM THE VENTILATOR WAS ALARMING AS EXPECTED AND ADEQUATELY. AS REQUESTED, THE DIRECTOR OF PATIENT SAFETY WAS PROVIDED WITH THE MOST CURRENT VERSION OF THE V60 SERVICE MANUAL TO GET INSTRUCTIONS ON HOW TO SET UP AND INSTALL THE TERA TERMINAL PROGRAM AND DOWNLOAD THE SIGNIFICANT EVENT LOG FROM THE VENTILATOR. THE DIAGNOSTIC NOTES FROM THE FIELD SERVICE ENGINEER (FSE) INDICATED THAT IP WAS VERIFIED, AND THERE WERE NO CRITICAL ERRORS IN THE DIAGNOSTIC REPORT (DRPT) LOG. THE UNIT PASSED ALL TESTS AND VERIFICATIONS AND WAS APPROVED FOR USE. PER THE DIAGNOSTICS PERFORMED BY THE FSE, THE SYSTEM MET THE SPECIFICATIONS FOR THE PERFORMED SERVICE AND WAS RETURNED TO USE. PER THE INITIAL INFORMATION RECEIVED FROM THE INSTITUTION'S DIRECTOR OF PATIENT SAFETY, THERE WAS NO DEVICE MALFUNCTION AND CAUSAL RELATIONSHIP OF THE DEATH WAS ATTRIBUTED TO HUMAN ERROR. BASED UPON THE INITIAL INFORMATION PROVIDED, THE SYSTEM MET THE MANUFACTURER DECLARED SPECIFICATIONS WITH NO CRITICAL ERRORS FOUND ON THE DRPT LOG. FURTHER ROOT CAUSE INVESTIGATION TO OBTAIN THE NATURE AND SPECIFICITY OF THE HUMAN ERROR IS CURRENTLY PENDING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872322 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Death