BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAD-87

    MDR report key: 4990561 · Received August 5, 2015

    Report

    Report Number
    2031172-2015-00988
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 8, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6), RESPIRATORY CARE MANAGER, CONTACTED MASIMO REGARDING A NEAR SENTINEL EVENT. THE TREND DATA DOWNLOAD FROM THE EVENT THROUGH SAFETY NET WAS REQUESTED. THE INCIDENT OCCURRED ON MONDAY, (B)(6), BETWEEN 5-6PM EST. THE INCIDENT OCCURRED IN RM. 114. THE OXIMETER STARTED TO ALARM. IT ALARMED TO THE FIRST THERAPIST AND SHE HAD THE PAGER ON VIBRATE AND AWAY FROM HER. IT THEN ALARMED TO THE NEXT LEVEL, AND THEY RESPONDED TO THE ALARM AND DISCOVERED THE TRACH TUBE HAD BEEN DISCONNECTED FROM THE PATIENT. THE PATIENT HAD NO PULSE, BUT WAS REVIVED. THE PATIENT IS IN CRITICAL CONDITION. (B)(6) WOULD LIKE TO REPORT ON HOW LONG IT TOOK FROM THE ALARM SOUNDING UNTIL THE THERAPISTS RESPONDED TO THE PATIENT. THE RAD-87 AND SAFETY NET WORKED PROPERLY IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519214 RAD-87 DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PATIENT SAFETYNET