BEUDAMED
    FDA Adverse Event Death Summary report: N

    BEDSIDE SPO2 MONITOR

    MDR report key: 6239147 · Received January 10, 2017

    Report

    Report Number
    2936999-2017-00023
    Event Type
    Death
    Date Received
    January 10, 2017
    Date of Event
    December 6, 2016
    Report Date
    December 13, 2016
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K142865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC REFERENCE NUMBER: (B)(4). PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT.   THE CUSTOMER DID NOT RETAIN THE SERIAL NUMBER WHICH DETERMINES THE DATE OF MANUFACTURE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE BEDSIDE SPO2 MONITOR DID NOT ALARM. THE CUSTOMER REPORTED THE PATIENT DIED ON (B)(6) 2016, CAUSE OF DEATH IS CURRENTLY UNDER INVESTIGATION WITH THE JURISDICTION AUTHORITIES. IN EVENT LOG. (B)(6) 2016 AT 0:02AM POWERED ON 0:25: CIRCUIT ALARM OCCURRED. FROM 0:28 TO 25 MUTE ALARM WAS PRESSED SEVERAL TIMES. 0:28 THE DEVICE TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20104 BEDSIDE SPO2 MONITOR PULSE OXIMETER DQA MEDIANA 10005941J

    Patients

    Seq Age Sex Outcome Treatment
    1 Death