BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD 9 PULSE OXIMETER

    MDR report key: 889742 · Received August 3, 2007

    Report

    Report Number
    2031172-2007-00001
    Event Type
    Death
    Date Received
    August 3, 2007
    Date of Event
    July 8, 2007
    Report Date
    August 3, 2007
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K993555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE TO THE COMPANY, THE INSTRUMENT WAS FUNCTIONING AS DESIGNED. IT APPEARS THAT THE PATIENT MAY HAVE DAMAGED THE SENSOR PRIOR TO OR AFTER PULLING OUT THE TRACH TUBE CAUSING A VISUAL ALARM OF "DEFECTIVE SENSOR" TO BE DISPLAYED ON THE INSTRUMENT. A VISUAL ALARM FOR A DEFECTIVE SENSOR IS NORMAL AND PERFORMS AS THE INSTRUMENT WAS DESIGNED. THE FDA'S DRAFT GUIDANCE DOCUMENT - PULSE OXIMETERS - PREMARKET NOTIFICATION SUBMISSIONS - PUBLISHED JULY 19, 2007 RECOMMENDS FOLLOWING ISO 9919 FOR ALARMS. ISO 9919 REFERS TO ISO 60601-1-8. ISO 60601-1-8 ONLY REQUIRES A VISUAL ALARM FOR LOW PRIORITY ALARMS. THE INSTRUMENT CONSIDERS A "DEFECTIVE SENSOR" TO BE A LOW PRIORITY ALARM. THEREFORE, IT ONLY PROVIDES A VISUAL ALARM. THIS IS ALSO DESCRIBED IN THE RAD 9'S USER MANUAL. THE COMPANY'S TESTING OF OTHER PULSE OXIMETERS SHOWS THAT OTHER COMPANIES SUCH AS NELLCOR, NONIN, AND BCI ONLY GIVE VISUAL ALARMS FOR A "DEFECTIVE SENSOR" FOR SOME OR ALL OF THEIR INSTRUMENTS. DESPITE THE DEVICE FUNCTIONING AS DESIGNED, AS DESCRIBED IN THE USER MANUAL, AND MEETING INDUSTRY STANDARDS, THE COMPANY HAS DECIDED TO RECALL THE RAD 9 AND PROVIDE A FREE SOFTWARE UPGRADE TO ALL CUSTOMERS WHO HAVE PURCHASED RAD 9'S THAT WILL ADD AN AUDIBLE ALARM TO THE CURRENT VISIBLE ALARM WHEN A DEFECTIVE SENSOR IS DETERMINED. PLEASE SEE THE ATTACHED RECALL LETTER TO THE CUSTOMERS. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    AN ELDERLY PATIENT WAS BEING MONITORED WITH A RAD 9 PULSE OXIMETER AND A LNCS ADTX DISPOSABLE SENSOR. THE PATIENT ALSO HAD A TRACH TUBE. THE HOSPITAL REPORTED THAT THE PATIENT WAS COMBATIVE AND HAD DAMAGED AT LEAST TWO OTHER SENSORS. THE HOSPITAL REPORTED THAT THEY FOUND THE PATIENT HAD DIED, AND THE TRACH TUBE WAS REMOVED AND THE MONITOR WAS SHOWING A VISIBLE DEFECTIVE SENSOR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAD 9 PULSE OXIMETER PULSE OXIMETER DQA MASIMO CORPORATION RAD 9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death