BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTWARE UPGRADE

    MDR report key: 19718330 · Received July 11, 2024

    Report

    Report Number
    9612330-2024-00035
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 25, 2024
    Report Date
    August 29, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    OLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). REF DOC-070476 REV 01 POST MARKET RISK ASSESSMENT, THE RISK IS CONSIDERED NEGLIGIBLE. INVESTIGATION RESULTS: AVERAGE SPO2 VALUES DISPLAYED IN REPORTS ARE NOT CORRECT. NEED TO RESOLVE THE INCORRECT CALCULATION OF AVERAGE SPO2 IN SLEEPWORKS 10. THE SOFTWARE ISSUE WAS ADDRESSED UNDER DEFECT NUMBER NW-25419. MITIGATING FACTORS: PROFESSIONALS ARE TRAINED TO REVIEW THE SCORED DATA AND THE REPORT FOR DIAGNOSIS PURPOSES SO THE ERROR IN THE REPORTS WOULD BE IDENTIFIED BEFORE THE HAZARDOUS SITUATION TO OCCUR. THE SOFTWARE WAS UPDATED TO CORRECT THIS SOFTWARE BUG. RELATED TO CAPA005689. NO FURTHER FOLLOW UP ACTION HAS BEEN RECORDED OR CROSS REFERENCED IN THIS COMPLAINT FOR AT LEAST 45 DAYS SINCE THE CUSTOMER'S LAST CONVERSATION. CUSTOMER HAS NOT CALLED BACK. REVIEW OF CUSTOMER'S ACCOUNT FOUND NO ADDITIONAL RELATED CALLS. COMPLAINT CASE WAS CLOSED 14 AUG 2024.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). NATUS SENT THE REPLACEMENT XLTEK EEG/PSG DELL OPTIPLEX XE4 SMALL FORM FACTOR SYSTEM (REPAIRED) (P/N 042867-R), AND MS WORD REPORT EDITOR FOR NEUROWORKS/SLEEPWORKS (P/N REPORT-EDITOR) TO THE CUSTOMER AS THE RESOLUTION. NO RELATED CAPAS. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    SOFTWARE UPGRADE: SLEEPWORKS 10 REPORTS DATA IS INCORRECT. SPO2 MEAN VALUE IS LOWER THAN STUDY'S MINIMUM SPO2 VALUE.

    Description of Event or Problem · 0

    SOFTWARE UPGRADE: SLEEPWORKS 10 REPORTS DATA IS INCORRECT. SPO2 MEAN VALUE IS LOWER THAN STUDY'S MINIMUM SPO2 VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384834 SOFTWARE UPGRADE SOFTWARE UPGRADE OLZ NATUS MEDICAL INCORPORATED LCUPGRADE 35377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown