BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SENSOR

    MDR report key: 6685 · Received September 23, 1993

    Report

    Report Number
    33638-1993-09003
    Event Type
    Injury
    Date Received
    September 23, 1993
    Date of Event
    February 9, 1993
    Report Date
    July 14, 1993
    Manufacturer
    CRITICARE SYSTEM, INC.
    Product Code
    KLK
    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 CRITICARE SYSTEMS POET MONITOR, WITH DISPODSABLE SENSOR.WE WERE NOTIFIED BY THE ATTENDING NURSE AT APPROXIMATELY 12:00 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 FACT THAT THE CHILD WAS NAPPING. A RESPIRATORY THERAPIST EMPLOYED BY THE DISTRIBUTOR. WAS DISPATCHED TO THE PATIENT'S HOME AT 2:30 TO TROUBLE SHOOT THE MACHINE. HE REMOVED THE DISPOSABLE PULSE OXIMETER FROM THE CHILD LEFT BIG TOE AND NOTICED WHAT APPEARED TO BE A BLACKENED TYPE OF BURN AREA. THE THERAPIST IMMEDIATELY CALLED HIS SUPERVISOR. THE SUPERVISOR AND ANOTHER PERSON WENT TO THE PATIENT'S HOME AT APPROXIMATELY 3:30 PM. THE POET MONITOR AND THE SENSOR INVOLVED WERE REMOVED FROM THE HOME.THE DISPOSABLE OXIMETER WAS SENT TO THE MANUFACTURER VIA FEDERAL EXPRESS. THE FINDINGS WERE THAT THIS PARTICULAR SENSOR HAD MALFUNCTIONED DUE TO AN ELECTROLYSIS PROCESS. THE PATIENT WAS SEEN AT A HOSPITAL BY A PLASTIC SURGEON. THE PATIENT'S WOUND IS EXPECTED TO HEAL IN APPROXIMATELY TWO TO THREE WEEKS. WE ARE CURRENTLY WAITING FOR A WRITTEN REPORT FROM THE PHYSICIAN ABOUT FINDINGS ON THIS INCIDENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. INVALID DATA - REGARDING 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. RESULTS OF EVALUATION: COMPONENT FAILURE, ELECTRICAL PROBLEM. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED 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 PULSE OXIMETER KLK CRITICARE SYSTEM, INC. R1290

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention