BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 14458935 · Received May 20, 2022

    Report

    Report Number
    2031642-2022-01378
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    May 9, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE GOOD FAITH EFFORTS HAVE BEEN REQUESTED TO GET MORE INFORMATION AND CLARIFICATION ON SEQUENCE AND TIMING OF EVENTS, DEVICE SETTINGS, CONFIGURATIONS, DIAGNOSTIC REPORT(DRPT) FINDINGS BUT WERE UNSUCCESSFUL..

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN THE END USER PLACED THE PATIENT ON A CHAIR, HIS SKIN BECAME CLAMMY, WITH PURPLISH NAIL DISCOLORATION AND RESCUE BREATHS WERE ADMINISTERED. THE V60 DEVICE WAS OBSERVED TO BE IN STANDBY MODE. DURING CLINICAL AND THERAPEUTIC USE OF V60 VENTILATOR, A MALE PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY EXPERIENCED CLAMMINESS OF THE SKIN WITH PURPLISH NAIL DISCOLORATION WHEN HE WAS PLACED ON A CHAIR. THE END USER OBSERVED THAT THE DEVICE WAS IN A STANDBY MODE. THE PATIENT RECEIVED RESCUE BREATHS, AND THE UNIT WAS PLACED BACK ONTO THE PATIENT FOR AN UNSPECIFIED PERIOD WITH NO ISSUES UNTIL A RESPIRATORY THERAPIST WAS ABLE TO REPLACE THE VENTILATOR (UNKNOWN MAKE/MODEL). NO FURTHER PATIENT HARM OR INJURY WAS INCURRED. A PHILIPS FIELD SERVICE ENGINEER (FSE) DOWNLOADED AND VIEWED THE DIAGNOSTIC REPORT (DRPTA) AND DID NOT OBSERVE ANY SERVICE-RELATED DIAGNOSTIC CODES. THE FSE PERFORMED A FULL PREVENTATIVE MAINTENANCE (PM) AND NOTED THAT THE AIR FLOW ACCURACY TEST WAS OUT OF TOLERANCE. THE FSE WAS NOT ABLE TO DUPLICATE THE PROBLEM OF THE DEVICE GOING INTO STANDBY MODE. THE FSE ADVISED THE CUSTOMER THAT THE UNIT NEEDED TO BE REPAIRED BEFORE IT CAN BE PLACED BACK INTO SERVICE. THE CUSTOMER STATED THAT THEY WILL HANDLE THE UNIT REPAIR. BASED ON THE FINDINGS OF THE DEVICE EVALUATION PERFORMED BY THE FSE, AIR FLOW FAILURE COULD HAVE CONTRIBUTED TO THE FAILURE NOTED BY THE CUSTOMER. THE REPORTED SYMPTOM OF DEVICE GOING INTO A STANDBY MODE COULD NOT BE DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523312 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention