BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2190855 · Received August 4, 2011

    Report

    Report Number
    1056128-2011-00071
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 8, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLF
    PMA / PMN Number
    K081238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RELAYED TO THE STRYKER SUSTAINABILITY SOLUTIONS' WITHOUT ANY INFORMATION SUCH AS PROCEDURE DATES, PATIENT INFORMATION, OR AN EXACT QUALITY INVOLVED. THE DEVICES WERE NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. THE PACKAGING WAS NOT SAVED EITHER. THE COMPLAINT DEVICES ARE NOT APPROPRIATE FOR NEONATAL OR INFANT APPLICATION PER SSS'S INSTRUCTIONS FOR USE. SINCE THE COMPLAINT DEVICES WERE NOT RETURNED FOR EVALUATION, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. A POTENTIAL CAUSE IS USING AN ADULT PULSE OXIMETER ON AN INFANT. ALL REPROCESSED PULSE OXIMETER SENSORS ARE SUBJECTED TO 100% TESTING PRIOR TO RELEASE. THIS IS THE FIRST COMPLAINT FOR THIS DEVICE RELATED TO BURNS THAT STRYKER SUSTAINABILITY SOLUTIONS HAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN PASSING THAT THE USER FACILITY HAD EXPERIENCED ADULT PULSE OXIMETERS CAUSING BURNS TO INFANTS WHEN USED. NO SPECIFIC DETAILS WERE GIVEN AND THE USER FACILITY STATED THERE WAS NO INJURY TO ANY OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLF NLF STRYKER SUSTAINABILITY SOLUTIONS 2320 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other