BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELCOR N-395 PULSE OXIMETER

    MDR report key: 1270127 · Received December 17, 2008

    Report

    Report Number
    2936999-2008-00629
    Event Type
    Death
    Date Received
    December 17, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 17, 2008
    Manufacturer
    NELLCOR PURTITAN BENNETT
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REQUESTED THAT THE UNIT BE RETURNED FOR INVESTIGATION. INFORMATION RECEIVED INDICATES THAT THE UNIT WAS HELD BY THE HOSPITAL'S RISK MANAGEMENT GROUP. ANOTHER DEVICE WAS ALSO EARLIER REPORTED ON 03/10/2008 TO COVIDIEN'S TECHNICAL SERVICE GROUP AS HAVING BEEN DROPPED AND DAMAGED. ON 03/10/2008, CUSTOMER FIRST REQUESTED TO RETURN THE UNIT FOR INVESTIGATION AND REPAIR. ON 04/15/2008, CUSTOMER NOTIFIED COVIDIEN THAT THEY DECIDED NOT TO RETURN THIS UNIT FOR SERVICE. THE DAMAGE REPORTED INCLUDED A CRACKED BEZEL WITH A MISSING PLATE TO WHICH THE SENSOR CABLE ATTACHES. CUSTOMER DECLINED TO RETURN THE UNIT FOR INVESTIGATION; THEREFORE, COVIDIEN IS UNABLE TO CONDUCT AN EVALUATION ON THE UNIT OR TO REVIEW TREND DATA STORED IN THE UNIT. THE FOLLOWING SECTIONS HAVE BEEN COPIED FROM THE NELLCOR N-395 PULSE OXIMETER OPERATOR'S MANUAL, 'START-UP AND USE'. PAGE 32. NOTE: VERIFY THAT INDICATORS, DISPLAY INFORMATION, AND AUDIBLE SOUNDS INCLUDING ALARMS ARE OPERATIONAL, INDICATING THAT THE MONITOR IS FUNCTIONING. EACH VALID BUTTON PRESS SHOULD GENERATE AN APPROPRIATE AUDIBLE OR VISUAL ACTION. OBSERVE MOVEMENT OF THE PULSE AMPLITUDE INDICATOR OR PLETH WAVEFORM, AND LISTEN FOR PULSE BEEPS TO VERIFY THAT MEASUREMENTS ARE BEING MADE. NOTE: IF ANY ACTION DOES NOT SEEM APPROPRIATE, DO NOT USE THE MONITOR. INSTEAD CONTACT NELLCOR PURITAN BENNETT TECHNICAL SERVICES DEPARTMENT OR YOUR LOCAL NELLCOR PURITAN BENNETT REPRESENTATIVE. IN MONITORING MODE, IF ACQUIRED PULSE IS LOST, THE MONITOR ENTERS PULSE SEARCH MODE. PULSE SEARCH. IF THE ACQUIRED PULSE IS LOST DURING MONITORING, THE N-395 ENTERS PULSE SEARCH. DURING PULSE SEARCH, THE MONITOR ATTEMPTS TO DETECT A PULSE FROM WHICH TO TAKE A MEASUREMENT. AT INITIAL POWER-UP (SENSOR ATTACHED TO MONITOR). IMMEDIATELY AFTER POST IS COMPLETED AND THE N-395 DISPLAYS ITS SOFTWARE VERSION NUMBER, THE MONITOR ENTERS PULSE SEARCH MODE AND THE PULSE SEARCH INDICATOR LIGHTS. IF AN ATTACHED SENSOR IS NOT CONNECTED TO A PATIENT, THE DISPLAY READS ZEROES AND THE MONITOR REMAINS IN THE PULSE SEARCH MODE FOR ABOUT 5 SECONDS. AFTER 5 SECONDS, THE PULSE SEARCH IS TURNED OFF AND THE SPO2 AND PULSE RATE DISPLAY "---&---" (DASHES AND DASHES). IF THE SENSOR IS CONNECTED TO THE PATIENT, THE N-395 ENTERS THE MONITORING MODE WHEN A PULSE SEARCH IS DETECTED. AT INITIAL POWER-UP (NO SENSOR ATTACHED TO MONITOR). IMMEDIATELY AFTER POST IS COMPLETED AND THE N-395 DISPLAYS ITS SOFTWARE VERSION NUMBER, THE MONITOR DISPLAYS DASHES. IT DOES NOT ENTER PULSE SEARCH MODE. PAGE 33. AFTER TAKING MEASUREMENTS. IF A PULSE SEARCH WAS PREVIOUSLY ACQUIRED AND THEN LOST, THE N-395 ENTERS PULSE SEARCH, AND THE PULSE SEARCH INDICATOR LIGHTS. THE LAST DETECTED READINGS ARE DISPLAYED WHILE THE MONITOR SEARCHES FOR A VALID PULSE. WHEN THE MONITOR CONSIDERS THE PULSE "LOST", IT DISPLAYS ZEROES AND A HIGH PRIORITY ALARM SOUNDS. WHEN A VALID PULSE IS DETECTED, THE N-395 EXITS THE PULSE SEARCH MODE AND DISPLAYS THE CURRENT READINGS. THE PULSE SEARCH INDICATOR GOES OUT. SENSOR OFF. IF THE SENSOR BECOMES DISCONNECTED FROM THE PATIENT DURING MONITORING, A LOW PRIORITY ALARM SOUNDS, VALUES FOR SPO2 AND PULSE RATE ARE REPLACED WITH DASHES, AND SENSOR OFF IS DISPLAYED ON THE SCREEN.

    Description of Event or Problem · 1

    ON 12/04/2008, COVIDIEN RECEIVED INFORMATION FROM A HOSPITAL RESPIRATORY THERAPIST THAT A SENTINEL EVENT HAD OCCURRED. IT IS REPORTED THAT THE PATIENT WAS LAST CHECKED AT 1545 HOURS AND HAD AN SPO2 OF 96-97%, AND AT 1640 HOURS THE PATIENT WAS NON-RESPONSIVE AND WAS CODED WITH THE PATIENT NOT RECOVERING. COVIDIEN DETERMINED THAT THE PATIENT HAD DIED. CALLER PROVIDED INFORMATION THAT THE READINGS FOR SPO2 AND PULSE RATE WERE DISPLAYING DASHES AND WAS NOT ALARMING. CALLER STATES THAT A SENSOR WAS ATTACHED TO THE PATIENT'S BIG TOE. CALLER COULD NOT IDENTIFY THE MANUFACTURER OF THE SENSOR WITH CERTAINTY BUT STATED THAT THE SENSOR WAS EITHER A DOLPHIN MEDICAL OR A NELLCOR SENSOR. COVIDIEN DISCUSSED WITH CALLER THAT THE SENSOR HAS TO HAVE A VALID SIGNAL AND CAPTURE THAT SIGNAL TO ALARM. CALLER STATED THAT HE DID NOT THINK THAT THE EQUIPMENT HAD MALFUNCTIONED. CALLER STATED THAT THE HOSPITAL HAD FILED A MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELCOR N-395 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURTITAN BENNETT N-395

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death