BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCI OXIMETER AUTO CORR

    MDR report key: 15397561 · Received September 10, 2022

    Report

    Report Number
    3012307300-2022-18485
    Event Type
    Malfunction
    Date Received
    September 10, 2022
    Report Date
    September 10, 2022
    Manufacturer
    ST PAUL
    Product Code
    DQA
    UDI-DI
    10610586036347
    PMA / PMN Number
    K070732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW IS NOT RELEVANT DUE TO THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THERE IS NO PHYSICAL DAMAGE ON THE DEVICE. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. INITIAL REPORTER IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10009406, AS A RESULT OF WARNING LETTER CMS# (B)(4)..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HADE AN ERROR CODE AND WOULD NOT TURN ON. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307870 BCI OXIMETER AUTO CORR OXIMETER DQA ST PAUL 3304 10610586036347

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown