BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM

    MDR report key: 10627591 · Received October 5, 2020

    Report

    Report Number
    3007409280-2020-00050
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 30, 2020
    Report Date
    September 30, 2020
    Manufacturer
    COVIDIEN LLC
    Product Code
    DQA
    PMA / PMN Number
    K142865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS PART OF THE LOANER POOL THAT AHS MAINTAINS FOR MASIMO CORPORATION. THE COMPLAINT STATES THAT THE DEVICE STOPPED WORKING IN THE MIDDLE OF AN OPEN-HEART CASE. THERE WAS NO MEDICAL INTERVENTION OR PATIENT HARM. THERE WAS NO DELAY IN TREATMENT. THE PATIENT WAS NOT UNDER ANESTHESIA AT THE TIME OF THE REPORTED EVENT. THE DEVICE WAS CONNECTED TO A B650 HOST MONITOR AT THE TIME OF THE REPORTED EVENT AND THE PDM WAS DISPLAYING A FULL BATTERY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE CASING IS IN GOOD CONDITION WITHOUT ANY COSMETIC DEFECTS OR DAMAGE. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE MONITOR FAILED BEFORE IT WAS PLACED ON THE PATIENT IN THE O.R. THE CUSTOMER STATED IF IT HAD BEEN ON THE PATIENT, THERE IS POTENTIAL FOR HARM DUE TO THE MONITOR NOT DISPLAYING THE PATIENT'S VITALS DURING SURGERY. TECHNICAL EVALUATION IDENTIFIED NO DISPLAY AND A DEFECTIVE FLEX CABLE. THE DEVICE WAS CHECKED FOR CASE DAMAGE, THE CIRCUIT BOARDS WERE INSPECTED AND THE UNIT WAS TESTED ON A SIMULATOR AND PASSED. THE CUSTOMER COMPLAINT WAS CONFIRMED; HOWEVER, THE REPORTED FAILURE WAS NOT RELATED TO A PREVIOUS SERVICE OR REPAIR. THE ROOT CAUSE WAS DETERMINED TO BE AGED PARTS RESULTING IN A FLEX ASSEMBLY FAILURE. THE CONNECTORS ARE USED HEAVILY. EACH TIME THE DEVICE IS USED SOMETHING MUST BE ATTACHED TO IT VIA A CONNECTOR. THE CONNECTOR IN QUESTION IS USED 5 - 10 TIMES MORE THAN THE OTHERS DUE TO THE TYPE OF MONITOR IT CONNECTS TO. THIS PARTICULAR CONNECTOR HAS A FLEX ON THE BACK THAT ATTACHES IT TO THE BOARD. THE FLEX CONNECTOR WAS REPLACED. A QC CHECKLIST WAS CONDUCTED TO INCLUDE THE FOLLOWING: DISPLAY TEST, POWER ON TEST, PARAMETER TEST AND A FINAL VISUAL INSPECTION ALL PASSED. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    THE DEVICE IS PART OF THE LOANER POOL THAT AHS MAINTAINS FOR MASIMO CORPORATION. THE DEVICE STOPPED WORKING IN THE MIDDLE OF AN OPEN HEART CASE. THERE WAS NO MEDICAL INTERVENTION OR PATIENT HARM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089455 NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM DQA COVIDIEN LLC FMGE1000

    Patients

    Seq Age Sex Outcome Treatment
    1