BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBRA BEDSIDE

    MDR report key: 22793516 · Received August 13, 2025

    Report

    Report Number
    2936999-2025-00421
    Event Type
    Death
    Date Received
    August 13, 2025
    Date of Event
    July 14, 2025
    Report Date
    December 17, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    DQA
    PMA / PMN Number
    NONE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3. MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. IT WAS REPORTED THAT AT THE TIME OF THE PATIENT'S DEATH, THE ALARM SOUND OF THE MONITOR COULD NOT BE CONFIRMED. THE SAT MESSAGE AND TREND DATA INFORMATION INDICATED ALARM CONDITIONS, INCLUDING "PULSE RATE LOWER LIMIT" AND "PULSE SEARCH." HOWEVER, DURING SUBSEQUENT TESTING OF THE MONITOR, THE ALARM SOUND WAS CONFIRMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AT THE TIME OF THE PATIENT'S DEATH, THE ALARM SOUND OF THE MONITOR COULD NOT BE CONFIRMED. THE SAT MESSAGE AND TREND DATA INFORMATION INDICATED ALARM CONDITIONS, INCLUDING "PULSE RATE LOWER LIMIT" AND "PULSE SEARCH." HOWEVER, DURING SUBSEQUENT TESTING OF THE MONITOR, THE ALARM SOUND WAS CONFIRMED. THE DEVICE MALFUNCTION WAS NOT RELATED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AT THE TIME OF THE PATIENT'S DEATH, THE ALARM SOUND OF THE MONITOR COULD NOT BE CONFIRMED. THE SAT MESSAGE AND TREND DATA INFORMATION INDICATED ALARM CONDITIONS, INCLUDING "PULSE RATE LOWER LIMIT" AND "PULSE SEARCH." HOWEVER, DURING SUBSEQUENT TESTING OF THE MONITOR, THE ALARM SOUND WAS CONFIRMED. THE DEVICE MALFUNCTION WAS NOT RELATED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62425 LIBRA BEDSIDE OXIMETER DQA COVIDIEN LLC N-BSJP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death