BEUDAMED
    FDA Adverse Event Death Summary report: N

    LNCS ADTX ADHESIVE SENSOR

    MDR report key: 5078076 · Received September 15, 2015

    Report

    Report Number
    2031172-2015-01084
    Event Type
    Death
    Date Received
    September 15, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 20, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K060143
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    LOT# UPDATED TO K15EDM. RETURNED TO MANUFACTURER DATE UPDATED TO 09/04/2015. ADDED MASIMO PATIENT CABLE. THE RETURNED SENSOR WAS EVALUATED. THE SENSOR FAILED VISUAL INSPECTION AS THE SENSOR CABLE WAS PULLING OUT OF THE SENSOR END. THIS EXPOSES THE INTERNAL WIRE JACKETS AND EMITTER ASSEMBLY. IN THIS CONDITION, THE SENSOR IS UNABLE TO ENGAGE IN PATIENT MONITORING. WHEN TESTED WITH KNOWN GOOD EQUIPMENT, AN ERROR MESSAGE WAS DISPLAYED ON THE MONITORING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NURSE MRS. (B)(6) CONTACTED MASIMO REPRESENTATIVE AND STATED THAT ON (B)(6) 2015 A PATIENT NEEDED TO BE REVIVED AFTER THEY FOUND HIM WITH NO VITAL SIGNS ON THE BED. AT THAT TIME THE PATIENT WAS MONITORED WITH A GE DASH 3000 MULTI-PARAMETER MONITOR. ACCORDING TO MRS. (B)(6), THE MONITOR/CENTRAL STATION WAS SHOWING THE ALARM "SENSOR DISCONNECTED". AT THIS TIME THE PATIENT WAS MONITORED WITH ONLY SPO2 WITH AN LNCS ADT SENSOR. THE PATIENT DID REFUSED TO BE MONITORED WITH ECG. THE SENSOR WAS REPORTED THAT LED AND WIRES WERE DISCONNECTED FROM THE ADHESIVE. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL (THE NAME OF THE HOSPITAL WAS NOT REPORTED) AND DIED AFTER SOME TIME. (B)(6) REPORTED TO MASIMO REPRESENTATIVE THAT HE WAS THE FIRST PHYSICIAN ON SITE AFTER A NURSE (NAME WAS NOT MENTIONED) FOUND THE PATIENT WITH NO VITAL SIGNS. HE CONFIRMED THE REPORTED SITUATION FROM MRS. (B)(6). HE ADDED THE INFORMATION THAT WHEN HE ARRIVED THE SENSOR WAS CONNECTED TO THE PATIENT WITH AN EXPOSED LED. AT THE TIME HE ARRIVED AT THE PATIENT, NO ALARM WAS PRESENT OR DISPLAYED. HE MENTIONED THAT ALL DATA RECORDS (MONITOR AND CENTRAL STATION) WERE AUTOMATICALLY DELETED AFTER 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609298 LNCS ADTX ADHESIVE SENSOR OXIMETER DQA MASIMO CORPORATION 1859 K15EDM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death