BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 12305088 · Received August 10, 2021

    Report

    Report Number
    2031642-2021-04531
    Event Type
    Death
    Date Received
    August 10, 2021
    Date of Event
    June 28, 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
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: B1: ADVERSE EVENT AND PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    PATIENT IMPACT CODE UPDATED BASED ON PREVIOUS INFORMATION SUBMITTED. FURTHER GOOD FAITH EFFORTS WERE ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING DEVICE EVALUATION WITH NO RESPONSE FROM THE REPORTER. BASED UPON THE INFORMATION PROVIDED, THE DEVICE PROTECTIVE MEASURES FUNCTIONED AS DESIGNED AND APPROPRIATELY. HOWEVER, DUE TO UNINTENTIONAL USE ERROR THE LOW RESPIRATORY RATE ALARM HAD BEEN OVERRIDDEN AND DEFEATED BY THE SET DEVICE RESPIRATORY RATE FREQUENCY. DUE TO THIS UNINTENTIONAL USE ERROR, THE PATIENT EPISODE OF APNEA DID NOT PROVIDE AN AUDIBLE OR VISUAL DEVICE ALERT TO THE CLINICAL END USER AND THE PATIENT SUBSEQUENTLY EXPIRED. DEVICE INHERENTLY SAFE DESIGN RISK CONTROL MEASURES PERMIT PATIENTS WITHIN LABELLED INDICATIONS FOR USE TO CONTINUE SPONTANEOUS BREATHING WHILE CONNECTED TO THE VENTILATOR IN THE EVENT OF A COMPLETE CESSATION OF FLOW/THERAPY. ADDITIONALLY, THE DEVICE PROVIDES VISUAL NOTIFICATION VIA THE GRAPHIC USER INTERFACE TO ALERT THE CLINICAL END USER THAT THE LOW RESPIRATORY RATE ALARM HAS BEEN RENDERED NON-FUNCTIONAL WHEN SET BELOW THE DEVICE DELIVERED RESPIRATORY RATE FREQUENCY. NO CAUSAL RELATIONSHIP OF THE DEVICE TO THE PATIENT OUTCOME HAS BEEN NOTED, HOWEVER THE UNINTENTIONAL USE ERROR OF INAPPROPRIATELY SET ALARM THRESHOLDS HAS BEEN DETERMINED TO BE CONTRIBUTORY TO THE PATIENT OUTCOME. ROOT CAUSE HAS BEEN DETERMINED AS UNINTENTIONAL USE ERROR RELATED TO PROPERLY SETTING THE DEVICE LOW RESPIRATORY RATE ALARMS AND POTENTIAL CONTRAINDICATED USE OF THE V60 VENTILATOR.

    Additional Manufacturer Narrative · 0

    DURING FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER STATED THE INTENT OF REPORTING THIS EVENT WAS NOT TO REPORT A PRODUCT MALFUNCTION BUT TO INQUIRE ABOUT FUTURE SOFTWARE UPGRADES AND PROVIDED ADDITIONAL INFORMATION ABOUT THE INCIDENT. THE PATIENT WAS VERY ILL AND PLACED ON A NON-INVASIVE VENTILATOR FOR RELIEF/ COMFORT, ACCORDING TO THE CUSTOMER. THE VENTILATOR SETTINGS WERE SET AT A BACKUP RATE OF 10 AND AN ALARM RATE OF 1, CAUSING NO ALARMS WHEN THE PATIENT EXPIRED. THERE WAS NO EXTERNAL/ NURSE CALL SYSTEM WAS CONNECTED AT THE TIME OF THE EVENT. BASED ON THE INFORMATION, THE PATIENT'S DEMISE WAS NOT RELATED TO A PRODUCT MALFUNCTION AS THE VENTILATOR WORKED AS INTENDED. THE CUSTOMER DID NOT REQUEST PHILIPS TO EVALUATE THE DEVICE.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 10AUG2021. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE DELIVERING THERAPY TO A PATIENT, THE RESPIRONICS V60 VENTILATOR CONTINUED TO DELIVER THE SET RATE OF 10 BREATHS PER MINUTE WHEN THE PATIENT EXPERIENCED AN EVENT OF APNEA, THE DEVICE DID NOT GENERATE A LOW-RATE ALARM, AND THE PATIENT EXPERIENCED AN OUTCOME OF DEATH. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED DEVICE BEHAVIOR, ADVERSE EVENT, AND PATIENT OUTCOME. THIS REPORTER STATED THAT A PATIENT OF UNKNOWN AGE, GENDER, HEIGHT, AND WEIGHT IN VERY POOR CONDITION WITH A POOR PROGNOSIS; DETAILS NOT REPORTED, WAS ADMITTED TO A HOSPITAL ON AN UNKNOWN DATE WITH AN ADMITTING DIAGNOSIS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE EXACERBATION. RELEVANT MEDICAL HISTORY INCLUDED CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); DIAGNOSIS DATE NOT REPORTED. NO RELEVANT PAST DRUG HISTORY OR RELEVANT CONCOMITANT MEDICAL PRODUCTS WERE REPORTED. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS PRESCRIBED NON-INVASIVE VENTILATION THERAPY VIA THE RESPIRONICS V60 VENTILATOR IN SPONTANEOUS / TIMED (S/T) MODE WITH THE LOW-RATE ALARM SET TO 1 BREATH PER MINUTE AND THE BACK-UP RATE SET TO 10 BREATHES PER MINUTE. THE PRESCRIPTION, DEVICE SETTINGS, CONFIGURATION, PATIENT CIRCUIT, AND PATIENT INTERFACE WERE NOT REPORTED. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS RECEIVING THERAPY VIA THE V60 DEVICE, WAS NOT BEING CONTINUOUSLY MONITORED, THE PATIENT BECAME APNEIC, THE V60 DID NOT GENERATE ANY AUDIBLE OR VISUAL ALARMS, THE V60 CONTINUED TO DELIVER BREATHS AT THE SET RATE OF 10 PER MINUTE, AND THE PATIENT EXPERIENCED AN OUTCOME OF DEATH. THE DATE AND CAUSE OF DEATH WERE NOT REPORTED. NO RELEVANT LABORATORY DATA WAS REPORTED. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198606 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death