BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 8929908 · Received August 26, 2019

    Report

    Report Number
    2031642-2019-07170
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Report Date
    June 7, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    UDI-DI
    00884838020054
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REMOVED UDI (B)(4). SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 26AUG2019. CUSTOMER SUPPORT ADVISED CALLER TO RESTART THE DEVICE, CHECK THE MACHINE, FOUND THE DEVICE'S BACKUP ALARM HAS DI-DI SOUND, ADVISED TO RE-PLUG THE CABLE TO THE MAN MACHINE INTERFACE (MMI) BOARD, THE SOUND DISAPPEARED, DETERMINED THE DATA ACQUISITION (DA) BOARD IS THE PROBLEM IN CONNECTION WITH THE CABLE. RESET MMI J15 BACKUP ALARM CABLE, BOOT UP CHECK: PASSED, DEVICE RETURNED TO FULL FUNCTIONALITY. NO PARTS WERE RETURNED TO FAILURE INVESTIGATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ABNORMAL ALERT SOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725898 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1