BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 14876488 · Received June 30, 2022

    Report

    Report Number
    2031642-2022-01764
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 22, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING INSTITUTION PHONE NUMBER - (B)(6). REPORTER PHONE NUMBER - (B)(6).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT WHILE THE V60 DEVICE WAS IN CLINICAL USE, THE MAIN POWER CORD WAS ACCIDENTALLY UNPLUGGED FROM THE V60 DEVICE BY THE END USER. AS A RESULT, THE DEVICE STOPPED WITHOUT THE BACKUP BATTERY TAKING OVER. THE SCREEN REMAINED BLANK AND WAS NOT DELIVERING VENTILATION, AND THE ALARM WOULD NOT STOP DESPITE REPLUGGING THE DEVICE. IN THE MEANTIME, THE PATIENT¿S OXYGEN SATURATION DROPPED TO 40%, HAD RESPIRATORY DISTRESS, AND CONSEQUENTLY HAD A PANIC ATTACK. THE END USER HAD TO USE AN ALTERNATIVE METHOD OF VENTILATION. THE MALFUNCTIONING V60 VENTILATOR WAS TRANSITIONED TO ANOTHER DEVICE (UNKNOWN MAKE/MODEL). THE DEVICE WAS EVALUATED BY THE CUSTOMER IN THEIR BIOMEDICAL DEPARTMENT. THE EVENT SIGNIFICANT LOG (DRPT) GENERATED DIAGNOSTIC CODES OF 1124 (CBITBATTERYFAILED) ON THE FOLLOWING DATES AND TIMES: 1124,12:01.53PM,06-19-2022,CBITBATTERYFAILED; 11:01.15AM,(B)(6)-2022,CBITBATTERYFAILED, AND 1:02.15AM,(B)(6)-2022,CBITBATTERYFAILED. THE DEVICE REINITIATED ON ITS OWN AND CYCLED BACK ON IN BETWEEN EPISODES OF THE CBIT BATTERY FAILURE. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONDUCTED AN ON-SITE EVALUATION ON (B)(6)-2022 AND WAS ABLE TO IDENTIFY THE ISSUE, WHICH WAS FOUND TO BE THE BATTERY OF THE V60 DEVICE. THE ORANGE CABLE CONNECTION OF THE BATTERY WAS FAULTY, AS EVIDENCED BY PHOTOS TAKEN. THE FSE REPLACED THE FAULTY BATTERY, WHICH RESOLVED THE ISSUE. BASED ON THE INFORMATION PROVIDED, PHILIPS WAS ABLE TO CONFIRM THE MALFUNCTION ASSOCIATED WITH THE FAULTY BATTERY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A VENTILATOR POWER CABLE WAS REPORTEDLY UNPLUGGED BY PERSONNEL BY ACCIDENT. THEREFORE, THE DEVICE STOPPED WITHOUT THE BATTERY TAKING OVER, THE SCREEN REMAINED BLACK AND WAS IMPOSSIBLE TO RESTART. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. BY THE TIME THE WARD PUT ANOTHER VENTILATOR IN PLACE, THE PATIENT DESATURATED TO 40%, RESPIRATORY DISTRESS, AND HAD AN ANXIETY ATTACK. IT IS UNKNOWN HOW LONG THE PATIENT WAS WITHOUT RESPIRATORY ASSISTANCE. DESPITE THE NEW CONNECTION AND THE CHANGE OF THE POWER OUTLET. IT WAS IMPOSSIBLE TO RESTART THE VENTILATION AND STOP THE ALARM. THEREFORE, THE DEVICE WAS ISOLATED AND REPLACED. THE DEVICE WAS EVALUATED BY THE CUSTOMER WHO CONFIRMED THE REPORTED ISSUE. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058988 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention