BEUDAMED
    FDA Adverse Event Death Summary report: N

    BSM-6700A

    MDR report key: 5158219 · Received October 16, 2015

    Report

    Report Number
    8030229-2015-00304
    Event Type
    Death
    Date Received
    October 16, 2015
    Report Date
    September 16, 2015
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K080342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A NELLCOR MAXN SPO2 SENSOR, MANUFACTURED BY MEDTRONIC/COVIDIEN, WAS ON A PATIENT THAT WAS CONNECTED TO NIHON KOHDEN'S BSM (BEDSIDE MONITOR). INFORMATION PROVIDED INDICATES THE PULSE OXIMETER HAD ALARMED INTERMITTENTLY. HOWEVER, DURING VITAL SIGN ROUNDS, THE SENSOR WAS NOTED TO BE OFF THE PATIENT BUT THE MONITOR WAS POSTING WITH NORMAL LIMIT READINGS. IT WAS REPORTED THAT THE PATIENT HAD EXPIRED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE, THIS WAS ALSO REPORTED BY MEDTRONIC/COVIDIEN UNDER MANUFACTURER REPORT NUMBER 2936999-2015-00806. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION. DEVICE EVALUATED BY MANUFACTURER. IT WAS REPORTED THAT A NELLCOR MAXN SPO2 SENSOR, MANUFACTURED BY MEDTRONIC, WAS ON A PATIENT THAT WAS CONNECTED TO NIHON KOHDEN'S BSM (BEDSIDE MONITOR). INFORMATION PROVIDED INDICATES THE PULSE OXIMETER HAD ALARMED INTERMITTENTLY. HOWEVER, DURING VITAL SIGN ROUNDS, THE SENSOR WAS NOTED TO BE OFF THE PATIENT BUT THE MONITOR WAS POSTING WITH NORMAL LIMIT READINGS. IT WAS REPORTED THAT THE PATIENT HAD EXPIRED. THE DEVICE WAS NEVER SENT IN FOR EVALUATION AS THE PROBLEM WAS NOT WITH THE DEVICE, BUT THE FACT THAT IT WAS NOT CORRECTLY PUT ON THE PATIENT'S FINGER. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NELLCOR MAXN SPO2 SENSOR, MANUFACTURED BY MEDTRONIC, WAS ON A PATIENT THAT WAS CONNECTED TO NIHON KOHDEN'S BSM (BEDSIDE MONITOR). INFORMATION PROVIDED INDICATES THE PULSE OXIMETER HAD ALARMED INTERMITTENTLY. HOWEVER, DURING VITAL SIGN ROUNDS, THE SENSOR WAS NOTED TO BE OFF THE PATIENT BUT THE MONITOR WAS POSTING WITH NORMAL LIMIT READINGS. IT WAS REPORTED THAT THE PATIENT HAD EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688745 BSM-6700A VITAL SIGN MONITOR MHX NIHON KOHDEN CORPORATION BSM-6700A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other