BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O3 PEDIATRIC SENSOR

    MDR report key: 15262343 · Received August 19, 2022

    Report

    Report Number
    3019388613-2022-00183
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    August 1, 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
    NURSE
    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: OTHER, OTHER TEXT: D 2 WAS LISTED AS OXIMETER, IS OXIMETER, TISSUE SATURATION,. E 4 WAS LISTED AS "NO", IS "YES", G. 5 WAS K160526, IS K182429; . H.1 WAS LISTED AS SERIOUS INJURY, IS MALFUNCTION. H3 OTHER TEXT : DEVICE NOT RECEIVED.

    Description of Event or Problem · 0

    PER MEDWATCH RECEIVED: "A PATIENT HAD PLACEMENT OF NIRS (NEAR-INFRARED SPECTROSCOPY) MONITORS ON THE LOWER LEFT FLANK. THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY AT THE LOCATION OF THE PROBE."

    Description of Event or Problem · 0

    PER MEDWATCH RECEIVED: "A PATIENT HAD PLACEMENT OF NIRS (NEAR-INFRARED SPECTROSCOPY) MONITORS ON THE LOWER LEFT FLANK. THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY AT THE LOCATION OF THE PROBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994511 O3 PEDIATRIC SENSOR OXIMETER, TISSUE SATURATION MUD MASIMO - 15750 ALTON PKWY 4235

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Other