BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O3 PEDIATRIC SENSOR

    MDR report key: 15263122 · Received August 20, 2022

    Report

    Report Number
    3019388613-2022-00184
    Event Type
    Malfunction
    Date Received
    August 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    August 12, 2022
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MUD
    PMA / PMN Number
    K182429
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: D2 WAS LISTED AS OXIMETER, IS OXIMETER, TISSUE SATURATION. E4 WAS LISTED AS "NO", IS "YES". G5 WAS K160526, IS K182429. H1: WAS LISTED AS SERIOUS INJURY, IS MALFUNCTION. H3 OTHER TEXT: DEVICE NOT RECEIVED.

    Description of Event or Problem · 0

    PER MEDWATCH RECEIVED: "PATIENT HAD PLACEMENT OF NIRS (NEAR-INFRARED SPECTROSCOPY) MONITORS ON RIGHT AND LEFT FLANKS AND DEVELOPED PRESSURE INJURIES AT BOTH SITES."

    Description of Event or Problem · 0

    PER MEDWATCH RECEIVED: "PATIENT HAD PLACEMENT OF NIRS (NEAR-INFRARED SPECTROSCOPY) MONITORS ON RIGHT AND LEFT FLANKS AND DEVELOPED PRESSURE INJURIES AT BOTH SITES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941047 O3 PEDIATRIC SENSOR OXIMETER, TISSUE SATURATION MUD MASIMO - 15750 ALTON PKWY 4235

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Other