BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SENSOR

    MDR report key: 5611 · Received May 10, 1993

    Report

    Report Number
    33638-1993-09001
    Event Type
    Injury
    Date Received
    May 10, 1993
    Date of Event
    February 9, 1993
    Report Date
    February 17, 1993
    Manufacturer
    CRITICARE SYSTEMS, INC.
    Product Code
    KXN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SIX MONTH OLD MALE WAS BEING MONITORED AT HOME FOR OXYGEN SATURATION ON A CRICICARE SYSTEMS POET MONITOR WITH A DISPOSABLE SENSOR. WE WERE NOTIFIED BY THE ATTENDING NURSE AT APPROX. 12:30 PM ON 2/9/93 THAT THE PULSE OXIMETER PORTION DID NOT SEEM TO BE FUNCTIONING PROPERLY. THE NURSE REQUESTED WE SCHEDULE A VISIT AT 2:30 DUE TO THE ACT THAT THE CHILD WAS NAPPING. A RESPIRATORY THERAPIST WAS DISPATCHED TO THE PATIENT'S HOME AT 2:30 TO TROUBLE SHOOT THE MACHINE. HE REMOVED THE DISPOSABLE PULSE OXIMETER SENSOR FROM THE CHILD'S LEFT BIG TOE AND NOTICED WHAT APPEARED TO BE A BLACKENED TYPE OF BURN AREA. THE THERAPIST IMMEDIATELY CALLED HIS SUPERVISOR WHO WENT TO THE PATIENT'S HOME AT 3:30P.M.. THE POET MONITOR AND THE SENSOR INVOLVED WERE REMOVED FROM THE HOME.THE DISPOSABLE PULSE OXIMETER SENSOR WAS SENT VIA FEDERAL EXPRESS TO MANUFACTURER. IT WAS REPORTED THE NEXT DAY THAT THIS PARTICULAR SENSOR HAD MALFUNCTIONED DUE TO AN ELECTROLYSIS PROCESS.THE PATIENT WAS SEEN AT A HOSPITAL BY A PLASTIC SURGEON RESIDENT. THE PATIENT'S PARENTS WERE TOLD THAT THE CHILD'S WOUND WOULD HEAL IN APPROXIMATELY TWO TO THREE WEEKS. WE ARE WAITING FOR A WRITTEN REPORT FROM THE PHYSICIAN ABOUT THE FINDINGS ON THIS INCIDENTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: ELECTRICAL TESTS PERFORMED. RESULTS OF EVALUATION: ELECTRICAL PROBLEM. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SENSOR KXN CRITICARE SYSTEMS, INC. 572 R1290

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention