BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VSI - NBP/SPO2

    MDR report key: 11620647 · Received April 6, 2021

    Report

    Report Number
    1218950-2021-10315
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 30, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DXN
    UDI-DI
    00884838028371
    PMA / PMN Number
    K112652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE DID NOT BEHAVE AS EXPECTED BY THE CUSTOMER. TO RESOLVE THE ISSUE, THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT SPEAKER. THE ABSENCE OF FURTHER CALLS SUPPORTS THAT THE REPORTED PROBLEM WAS RESOLVED. THE DEVICE REMAINS AT THE CUSTOMER'S FACILITY. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED BASED ON THE AVAILABLE INFORMATION AT THE TIME OF COMPLAINT CLOSURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AT STARTUP OF THE DEVICE, IT DISPLAYED AN ERROR MESSAGE "AUDIO FAILURE, LOUDSPEAKER DEFECT". THE DEVICE DOES NOT EMIT ANY SOUND. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT STARTUP OF THE DEVICE, IT DISPLAYED AN ERROR MESSAGE "AUDIO FAILURE, LOUDSPEAKER DEFECT". THE DEVICE DOES NOT EMIT ANY SOUND. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516295 SURESIGNS VSI - NBP/SPO2 SURESIGNS VSI - NBP/SPO2 DXN PHILIPS NORTH AMERICA LLC 863276 00884838028371

    Patients

    Seq Age Sex Outcome Treatment
    1