BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8 HORIZONTAL

    MDR report key: 5212991 · Received November 9, 2015

    Report

    Report Number
    2031172-2015-01288
    Event Type
    Death
    Date Received
    November 9, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 16, 2015
    Manufacturer
    MASIMO
    Product Code
    DQA
    PMA / PMN Number
    K053269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED WHICH INCLUDED FUNCTIONAL TESTING. DURING THIS TESTING THE UNIT PROVIDED BOTH AUDIBLE AND VISUAL ALARMS. FURTHER ANALYSIS OF THE FILES SHOWS AN UNEXPECTED DATE CHANGE FROM (B)(6) 2015 TO (B)(6) 2005. THIS HAS BEEN ATTRIBUTED TO A DEFECTIVE BATTERY REACHING A CRITICALLY LOW STATE OF CHARGE AND BEING UNABLE TO RECOVER. BATTERY IS DEFECTIVE CAUSING A SYSTEM/DATE RESET. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER SIX (6) YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT. CORRECTED DATA : TO INCLUDE PRODUCT PROBLEM. CORRECTED DATA: RESPIRATORY THERAPIST TO PATIENT/LAY USER. CORRECTED DATA : (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTEDLY, THE PARENTS CLAIM THE RAD-8 DID NOT ALARM TO ALERT THEM THAT THEIR CHILD WAS IN DISTRESS. HOWEVER, THE MASIMO REP ALSO STATED THAT THE RESPIRONICS VENTILATOR THE CHILD WAS ON ALSO DID NOT ALARM. BASED ON WHAT SOFT TOUCH MEDICAL WAS SAYING, THERE WAS NO APPARENT PROBLEM WITH THE RAD-8 EXCEPT THAT WHEN THEY DID A TREND PRINTOUT USING PROFOX, THE DATE AND TIME DID NOT MATCH. PER THE CUSTOMER (SOFT TOUCH) THEY DID A PRINTOUT USING PROFOX. THE DATE AND TIME SHOWING (B)(6) 2015 HOWEVER, AS OF (B)(6) AT 9:04AM, WHEN THE MASIMO REP SPOKE WITH THEM, THE RAD-8 WAS SHOWING (B)(6) 2005, 19 HOURS, 12 MINUTES. THE MASIMO REP STATED THAT SOFT TOUCH MEDICAL TOLD HIM THAT THE CHILD PASSED AWAY 2 DAYS AGO. UNKNOWN GENDER. THE CHILD HAD COME OUT OF NICU AND WAS NOT EXPECTED TO LIVE. "HAD A LOT OF MEDICAL ISSUES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740780 RAD-8 HORIZONTAL OXIMETER DQA MASIMO 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Death