BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPWORKS 10.X ACQUISITION SOFTWARE WITHOUT SPIKE / EVENT

    MDR report key: 19676344 · Received July 4, 2024

    Report

    Report Number
    9612330-2024-00036
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    June 3, 2024
    Report Date
    August 29, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    OLZ
    PMA / PMN Number
    K090277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4). UPDATE TO SECTION B3. LOT/SERIAL NUMBER: N/A. THE CUSTOMER RETURNED THE COMPLETED AE QUESTIONNAIRE. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVED, DEATH, OR SERIOUS INJURY. THE USER WAS HAVING ISSUE IN REPORTING. THE TITRATION REPORTING IS HAVING SPO2 VALUE UNCERTAINTY. REF (B)(4) REV 01 POST MARKET RISK ASSESSMENT, THE RISK IS CONSIDERED NEGLIGIBLE. FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/SOFTWARE FAILURE. THE SOFTWARE ISSUE WAS ADDRESSED UNDER DEFECT NUMBER NW-25419. THE SOFTWARE WAS UPDATED TO CORRECT THIS SOFTWARE BUG. RELATED TO ECR#22960 AND CAPA005689. COMPLAINT CASE CLOSED 10 AUG 2024.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT#(B)(4). UDI# NOT APPLICABLE. TECHNICAL SERVICE CREATED JIRA TICKET TPI-4267 FOR ENGINEERING INVESTIGATION. PER TPI-4267, THE CUSTOMER RAN THEIR CUSTOM REPORT ON A RECORDING IN SLEEPWORKS 10, THEY NOTICED THAT THE MEAN SPO2 WAS LOWER THAN THE MINIMUM SPO2 WHICH IS NOT LOGICAL, THE CUSTOMER THAN RAN THE SAME REPORT ON THE SAME DATA IN SLEEPWORKS 9.3 AND HERE IT SEEMED CORRECT (MEAN WAS HIGHER THAN MINIMUM). THE ANALYSIS WAS RE-RUN IN SLEEPWORKS 10, AND IT MADE NO DIFFERENCE. PER TPI-4267, ENGINEERING GENERATED A REPORT FOR THE SAME STUDY ON SOFTWARE VERSION 9.3 AND 10 AND ALL MEAN VALUES FOR SPO2 ARE LOWER WHEN REPORT IS GENERATED USING 10.0 AND ONE MEAN VALUE IS ACTUALLY LOWER THAN THE MIN SPO2 VALUE. TPI-4167 WAS CLOSED AS A CONFIRMED PRODUCT DEFECT. ISSUE IS BEING ADDRESSED UNDER NW-25419. NO EVIDENCE OF FOLLOW-UP ATTACHED AS DEVICE WILL NOT BE RETURNED, THIS IS A SOFTWARE ISSUE. NO RELATED CAPAS. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    LC200-10 SLEEPWORKS 10.X ACQUISITION SOFTWARE WITHOUT SPIKE / EVENT: MEAN SPO2 IN SW10 REPORTS IS LOWER THAN MINIMUM SPO2 - ALSO DIFFERENT THAN WHAT IS REPORTED IN SW9.3.1.

    Description of Event or Problem · 0

    LC200-10 SLEEPWORKS 10.X ACQUISITION SOFTWARE WITHOUT SPIKE / EVENT: MEAN SPO2 IN SW10 REPORTS IS LOWER THAN MINIMUM SPO2 - ALSO DIFFERENT THAN WHAT IS REPORTED IN SW9.3.1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255196 SLEEPWORKS 10.X ACQUISITION SOFTWARE WITHOUT SPIKE / EVENT SLEEPWORKS 10.X ACQUISITION SOFTWARE WITHOUT SPIKE / EVENT OLZ NATUS MEDICAL INCORPORATED LC200-10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown