BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE OXIMETRY/PLETHSMOGRAPHY MODULE

    MDR report key: 2030211 · Received March 16, 2011

    Report

    Report Number
    9610816-2011-00141
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 1, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K903523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE SPO2 MEASUREMENTS BEING PROVIDED BY THE MONITORING SYSTEM WERE INCORRECT (AS COMPARED TO BLOOD GAS ANALYSIS DATA). THE INITIAL INFORMATION FROM THE USERS INDICATED THAT THE PATIENT HAD APPROXIMATELY 62 PERCENT SATURATION BY BLOOD GAS ANALYSIS AND A 97/98 PERCENT SATURATION BY SPO2. THE INITIAL INFORMATION PROVIDED BY THE USERS INDICATED THAT THE PATIENT DID DIE, BUT THAT THE USE OF THE DEVICE WAS NOT A FACTOR IN THE DEATH. THE INFORMATION GATHERED FROM THE HOSPITAL'S BIOMEDICAL ENGINEER INDICATES THAT NURSING STAFF PLACED A SPO2 FINGER SENSOR ONTO THE PATIENT'S FOREHAND (LAID OUT FLAT AND TAPED IN PLACE) TO PERFORM SPO2 MEASUREMENTS. THIS IS INCORRECT USE OF THE SENSOR AND CAN RESULT IN INCORRECT SPO2 MEASUREMENT DATA. THERE WAS NO DEVICE MALFUNCTION. POST INCIDENT DEVICE TESTING PERFORMED BY A PHILIPS FIELD SERVICE ENGINEER (FSE) AND THE HOSPITAL BIOMEDICAL ENGINEER SHOWED THAT THE MONITORING SYSTEM WAS OPERATING PROPERLY AND WITHIN SPECIFIED LIMITS. PRODUCT LABELING (INSTRUCTIONS FOR USE FOR THE SPO2 SENSOR) ADEQUATELY DESCRIBES PROPER PLACEMENT OF THE SPO2 FINGER SENSOR. THE AVAILABLE INFORMATION SUPPORTS THAT THE USE OF THE DEVICE WAS NOT A FACTOR IN THE DEATH OF THE PATIENT, BUT INDICATES THAT THE DEVICE WAS BEING USED OUTSIDE NORMAL AND EXPECTED USE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE SPO2 MEASUREMENTS BEING PROVIDED BY THE MONITORING SYSTEM WERE INCORRECT (AS COMPARED TO BLOOD GAS ANALYSIS DATA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE OXIMETRY/PLETHSMOGRAPHY MODULE DQA PHILIPS MEDICAL SYSTEMS M1020A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death