BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONIN

    MDR report key: 1932240 · Received December 13, 2010

    Report

    Report Number
    2050001-2010-00002
    Event Type
    Other
    Date Received
    December 13, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    CAREFUSION 211, INC.
    Product Code
    DQA
    PMA / PMN Number
    K052669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K#, SENSOR - K092101. OXIMETER AND SENSOR MANUFACTURER: NONIN MEDICAL, INC. (B)(4). NOTE: THE DEVICE LABELING CONTAINS THE FOLLOWING CAUTION STATEMENT. "INSPECT THE SENSOR APPLICATION SITE AT LEAST EVERY 6 TO 8 HOURS TO ENSURE CORRECT SENSOR ALIGNMENT AND SKIN INTEGRITY. PT SENSITIVITY TO SENSORS MAY VARY DUE TO MEDICAL STATUS OR SKIN CONDITION." THE DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. (B)(4). CAREFUSION ISSUED A (B)(4) NUMBER TO THE DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY DEVICES (OXIMETER AND SENSOR) FOR EVALUATION. AS OF (B)(4) 2010, THE ALLEGED FAULTY DEVICES HAVE NOT BEEN RECEIVED. ONCE THEY HAVE BEEN RECEIVED, THEY WILL BE SENT TO THE MANUFACTURER FOR EVALUATION. UPON RECEIPT OF THE EVALUATIONS RESULTS, CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH THE DISTRIBUTOR'S REPRESENTATIVE. "[NAME REMOVED] FROM [DISTRIBUTOR'S NAME REMOVED] CALLED [NAME REMOVED] AT TECH SUPPORT WITH A PT COMPLAINT; SHE NOTES - PT RETURNED UNIT WITH COMPLAINT OXIMETER PROBE BURNED TIP OF FINGER. SHE DID NOT VISIBLY SEE A BURN. PT DESCRIBED, TIP OF FINGER WAS HOT TO THE TOUCH, PAINFUL TO THE POINT OF NEED OF APPLYING ICE TO AREA. T3 UNIT (B)(4); OXIMETER (B)(4); OXIMETER PROBE (B)(4) PT STATES WHEN HE WOKE UP THIS MORNING, HE HAD SEVERE PAIN IN HIS FINGER TIP - LIKE A SHARP PINCHING SENSATION, HE ALSO NOTES THERE IS A RED DISCOLORATION MARK REMAINING AT THE LOCATION. I SENT A REPLACEMENT NONIN BLUETOOTH OXIMETER, A FINGER PROBE ON (B)(4). WE ORIGINALLY THOUGHT TECH SUPPORT WOULD ISSUE THE RMA AND GET THE TIMES IN QUESTION BACK, BUT IT WAS LATER DETERMINED THAT I NEEDED TO ISSUE THE RETURN LABEL WHICH I DID ON (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN OXIMETER SENSOR DQA CAREFUSION 211, INC. 8000SM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other