BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE OXYMETER SENSOR

    MDR report key: 8686 · Received June 1, 1994

    Report

    Report Number
    8686
    Event Type
    Injury
    Date Received
    June 1, 1994
    Date of Event
    October 26, 1993
    Report Date
    October 29, 1993
    Manufacturer
    NONIN MEDICAL, INC.
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED IN THE MRI SCANNER. A PULSE OXYMETER SENSOR WAS PLACED ON THE FINGER. WHEN THE MRI WAS COMPLETED THE PULSE OXYMETER WAS REMOVED. A REDDENED AREA WAS NOTED ON THE SKIN WHERE THE OXYMETER HAD BEEN PLACED. ICE WAS APPLIED TO THE SITE. THE RADIOLOGIST SPOKE WITH THE PATIENT AND WAS REFERRED TO HER MD FOR FOLLOW-UP (OBSERVATION) OF SITE. NO FURTHER DAMAGE TO SITE AT PRESENT TIME.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE OXYMETER SENSOR N/A NONIN MEDICAL, INC. 8604 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention