BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 12914169 · Received December 1, 2021

    Report

    Report Number
    2031642-2021-05667
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    October 21, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838009851
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO PHILIPS THAT THE V60 VENTILATOR BLOWER MOTOR REQUIRED REPAIR DUE TO UNSPECIFIED REASONS IN ADDITION TO A REQUEST FOR DEVICE PREVENTATIVE MAINTENANCE. FURTHER INVESTIGATION FOUND THAT DURING CLINICAL AND THERAPEUTIC USE, THE DEVICE EXPERIENCED AN INOPERATIVE CONDITION DUE TO A BLOWER MOTOR FAILURE IN CONJUNCTION WITH AN ALLEGATION OF THE V60 VENTILATOR FAILING TO PROVIDE AN AUDIBLE OR VISUAL ALARM NOTIFICATION. FURTHER INVESTIGATION INTO THE EVENT IN QUESTION YIELDED ADDITIONAL INFORMATION OF A PATIENT SERIOUS ADVERSE EVENT. DURING CLINICAL AND THERAPEUTIC USE WITHIN AN INSTITUTIONAL INTENSIVE CARE UNIT (ICU), THE V60 VENTILATOR EXPERIENCED A BLOWER STALL CONDITION AND WENT INOPERABLE AND ALLEGEDLY PROVIDED NO VISUAL OR AUDIBLE ALARM. THE PATIENT WAS NOTED TO HAVE GONE INTO RESPIRATORY FAILURE DUE TO THIS EVENT. THE PATIENT WAS REMOVED FROM THE V60 VENTILATOR AND SUBSEQUENTLY MANUALLY VENTILATED, INTUBATED, PLACED INTO A MEDICALLY INDUCED COMA, AND PLACED ONTO A MECHANICAL VENTILATOR (MAKE AND MODEL UNSPECIFIED). FURTHER INVESTIGATION INTO PATIENT OUTCOME IS CURRENTLY PENDING. THE DEVICE WAS EVALUATED AND INVESTIGATED BY A PHILIPS SERVICE ENGINEER. DIAGNOSTIC REPORTS WERE RETRIEVED FROM THE VENTILATOR AND FURTHER INVESTIGATION CONFIRMED DIAGNOSTIC CODES RELATED TO BLOWER MOTOR FAILURE WITHIN THE REPORTS. DEVICE EVALUATION CONFIRMED THE FAILURE OF THE BLOWER MOTOR. ADDITIONALLY, THE DEVICE WAS NOTED TO HAVE A LOOSE COOLING FAN AND A BACKUP BATTERY GREATER THAN EXPECTED LIFE OF 5 YEARS. THE LOOSE COOLING FAN AND BACKUP BATTERY GREATER THAN EXPECTED LIFE OF 5 YEARS ARE NOT BELIEVED TO HAVE CAUSED NOR CONTRIBUTED TO THE BLOWER MOTOR FAILURE AND HAVE BEEN CAPTURED WITHIN PHILIPS¿S COMPLAINT DATABASE INDIVIDUALLY. THE BLOWER MOTOR WAS REPLACED BY THE PHILIPS SERVICE ENGINEER IN CONJUNCTION WITH REPLACEMENT OF THE ADDITIONAL PARTS: COOLING FAN, BACKUP BATTERY. PERFORMANCE VERIFICATION TESTING (PVT) WAS CONDUCTED STATUS POST REPLACEMENT OF PARTS YIELDING AN ADDITIONAL FAILURE MODE OF O2 MIX ACCURACY TEST FAILING. THE FLOW SENSOR ASSEMBLY WAS REPLACED, AND PVT CONDUCTED WITH ALL TESTS SUCCESSFULLY PASSING. THE FAILURE OF THE FLOW SENSOR ASSEMBLY HAS BEEN CAPTURED WITHIN PHILIPS¿S COMPLAINT DATABASE. BASED UPON THE INFORMATION PROVIDED, FAILURE OF THE V60 VENTILATOR BLOWER MOTOR HAS BEEN CONFIRMED. THE DEVICE WAS IN CLINICAL AND THERAPEUTIC USE AT THE TIME OF THE EVENT AND DUE TO THE UNEXPECTED DEVICE BLOWER MOTOR FAILURE, DEVICE CAUSE AND/OR CONTRIBUTION TO THE PATIENT SAE HAS BEEN CONFIRMED. THE DEVICE HAS UNDERGONE SUBSEQUENT INVESTIGATION, EVALUATION, AND SERVICING WITH NO FURTHER OCCURRENCE OF MALFUNCTION OF FAILURE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS. ROOT CAUSE OF THE BLOWER MOTOR FAILURE CANNOT BE DETERMINED AND IS PENDING RECEIPT BY PHILIPS FAILURE INVESTIGATIONS FOR FURTHER ROOT CAUSE ANALYSIS.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION REGARDING THE PATIENT OUTCOME WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS BY A CUSTOMER THAT THE UNIT REQUIRES A BLOWER REPAIR AND A PREVENTIVE MAINTENANCE. BASED UPON THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT, HOWEVER, NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED BY A BENCH TECHNICIAN AND CONFIRMED THE BLOWER ISSUE. THE BENCH TECHNICIAN FOUND THAT THE UNIT BLOWER WAS NOT SPINNING, BATTERY IS OVER 5 YEARS, AND FAN WAS LOOSE. ONCE THE BLOWER WAS REPLACED, A PERFORMANCE FUNCTIONAL CHECK WAS CONDUCTED, WHICH RESULTED IN THE UNIT FAILING THE O2 MIXED ACCURACY TEST. COMPLETE REPAIR INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805390 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening