BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBRA BEDSIDE SPO2 MONITOR

    MDR report key: 6197461 · Received December 21, 2016

    Report

    Report Number
    2936999-2016-01088
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 25, 2016
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K120773
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC REFERENCE NUMBER: (B)(4). PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) HAS BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT. MEDTRONIC IS ATTEMPTING TO GATHER ADDITIONAL INFORMATION SURROUNDING THE CIRCUMSTANCES ASSOCIATED TO THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THE BEDSIDE SPO2 MONITOR DID NOT GENERATE AN AUDIBLE ALARM. CUSTOMER CONFIRMED THE EXPIRED ALTHOUGH THE DATE OF PATIENT DEATH WAS NOT REPORTED. FOLLOW UP EFFORTS ARE BEING MADE TO GATHER ADDITIONAL INFORMATION SURROUNDING THE CIRCUMSTANCES OF THE CUSTOMER REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845820 LIBRA BEDSIDE SPO2 MONITOR PULSE OXIMETRY DQA MEDIANA 10005941

    Patients

    Seq Age Sex Outcome Treatment
    1 Death