BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 11946304 · Received June 7, 2021

    Report

    Report Number
    2031642-2021-03975
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 10, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DUE DILIGENCE AND MULTIPLE GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL RELEVANT INFORMATION WITH NO RESPONSE FROM THE CUSTOMER. CLINICAL DETAILS SURROUNDING THE EVENT OF INTUBATION, PATIENT OUTCOME, DEVICE RESOLUTION AND DISPOSITION, CONCLUSION AND ROOT CAUSE REMAIN UNKNOWN DUE TO LACK OF INFORMATION. THE COMPLAINT WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B4:27AUG2021. NEW INFORMATION WAS RECEIVED. THE DEVICE WAS IN USE ON A PATIENT; THE DEVICE STOPPED AND THE PATIENT NEEDED TO BE INTUBATED. THERE WAS A DELAY IN PROVIDING THERAPY. THE DIAGNOSTIC REPORT NOTES PRESSURE REGULATION HIGH ERROR OCCURRED ON (B)(6) 2021. ON (B)(6) 2021, A PHILIPS AUTHORIZED SERVICE PERSONNEL (ASP) WAS DISPATCHED TO THE CUSTOMER SITE TO IMPLEMENT FIELD CHANGE ORDER FOR THE POWER MANAGEMENT BOARD. THE PM PCBA WAS REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 07JUN2021.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAS ERROR MESSAGE- INOP CALL FOR SERVICE. THE DEVICE STOPPED ON A PATIENT. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND REQUESTED FOR SERVICE REPAIR. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON PATIENT, BUT THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847224 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention