BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SAFETY NET

    MDR report key: 5540180 · Received March 31, 2016

    Report

    Report Number
    2031172-2016-00459
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 17, 2016
    Report Date
    March 17, 2016
    Manufacturer
    MASIMO CORPORATION
    Product Code
    MSX
    PMA / PMN Number
    K071047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME WAS "RADIUS 7" SHOULD BE "PATIENT SAFETY NET." COMMON DEVICE NAME WAS "CO-OXIMETER, PRODUCT CODE: MWI" SHOULD BE "SUPPLEMENTAL ALARM SYSTEM; PRODUCT CODE: MSX." MODEL # WAS "24970" AND CATALOG # WAS "9664" SHOULD BE BLANK AS NO INFORMATION WAS PROVIDED. CORRECTED DATA: PMA/510(K) WAS "K142394" SHOULD BE "K071047."

    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 THE NURSE MANAGER NOTICED AN EVENT ON THE SAFETYNET VIEW IN THE RE-ESCALATION PHASE. SHE WENT TO THE ROOM TO INVESTIGATE. THE ROOT DEVICE DISPLAYED "RADIUS 7 DISCONNECTED", BUT THERE WERE NO AUDIBLE OR VISUAL ALARMS. THE RADIUS 7 WAS ATTACHED TO THE PATIENT. THE RADIUS 7 DISPLAYED DASHES, BUT IT ALSO HAD NO VISUAL OR AUDIBLE ALARMS. THE LIGHT ON THE NEO SENSOR WAS ILLUMINATED. THE NURSE DISCONNECTED THE BATTERY FROM THE RADIUS 7 MODULE AND THEN RECONNECTED IT. THE PATIENT DATA WAS THEN DISPLAYED ON THE RADIUS 7 AND THE ROOT. THERE HAVE BEEN NO NOTED ISSUES SINCE. THE NURSE REPORTED THAT SHE IS CONCERNED THAT THERE WERE NO AUDIBLE OR VISUAL ALARMS AT THE BEDSIDE DESPITE THE FACT THAT THE PATIENT WAS NOT BEING MONITORED. THE DIS-CONNECT AND RE-CONNECT SEEMED TO FIX THE ISSUE. NO DROP OUTS HAVE BEEN REPORTED SINCE. THE ISSUE WAS OBSERVED IN ROOM (B)(6). NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194510 PATIENT SAFETY NET SUPPLEMENTAL ALARM SYSTEM MSX MASIMO CORPORATION 24970

    Patients

    Seq Age Sex Outcome Treatment
    1