BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PB540 VENTILATOR

    MDR report key: 3896549 · Received May 19, 2014

    Report

    Report Number
    8020893-2014-01188
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    January 1, 2013
    Report Date
    December 9, 2013
    Manufacturer
    COVIDIEN, FORMERLY PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K082966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED BUZZER PCBA WAS REPORTED TO HAVE EXHIBITED THE FOLLOWING FAILURE: ;SPEAKER FAULT 4 39;. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED COMPONENT, NO ANOMALIES WERE OBSERVED. THE BUZZER PCBA WAS INSERTED INTO THE TEST VENTILATOR AND AFTER APPROXIMATELY 1 MINUTE, THE VENTILATOR ALARMED FOR SPEAKER FAULT 4 39;, VERIFYING THE CUSTOMER REPORTED FAILURE. SPEAKER FAULT 4 39; ALARMS WHEN THE VENTILATOR DETECTS THAT THE ALARM (BUZZER) BATTERY VOLTAGE IS LESS THAN 4.8 VOLTS OR GREATER THAN 9.5 VOLTS. THE VOLTAGE ON THE BUZZER PCBA BATTERY WAS MEASURED AND IT WAS CONFIRMED THAT THE VOLTAGE ON THE BUZZER PCBA BATTERY WAS LESS THAN 4.8 VOLTS. THE BATTERY WAS MANUFACTURED IN JUNE 2010. A CAPA WAS OPENED TO ADDRESS THE PREVENTATIVE MAINTENANCE FOR THIS COMPONENT, AND A SECOND CAPA WAS OPENED TO ADDRESS THE SPEAKER FAULT 4 39; ALARMS.

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE ALARM PRINTED CIRCUIT BOARD (PCB). THE CSE THEN UPDATED THE POWER MANAGEMENT SOFTWARE. THE CSE THEN COMPLETED ALL CALIBRATIONS AND CONDUCTED TOTAL PERFORMANCE VERIFICATION TESTING. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT A PB540 VENTILATOR GENERATED A CONTINUOUS ALARM. THE VENTILATOR GENERATED A CONTINUOUS ALARM. THE VENTILATOR WAS NOT CONNECTED TO A PATIENT WHEN THE MALFUNCTION OCCURRED. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND AN ERROR CODE IN THE MEMORY LOG RELEVANT TO THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297701 PB540 VENTILATOR CBK COVIDIEN, FORMERLY PURITAN PB540

    Patients

    Seq Age Sex Outcome Treatment
    1