BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, RAD-97 PULSE CO-OXIMETER

    MDR report key: 16765685 · Received April 18, 2023

    Report

    Report Number
    3019388613-2023-00128
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 22, 2023
    Report Date
    March 22, 2023
    Manufacturer
    MASIMO - 15750 ALTON PKWY
    Product Code
    MWI
    UDI-DI
    00843997012317
    PMA / PMN Number
    K193626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: 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., OTHER, OTHER TEXT: INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6). INITIAL REPORTER PHONE NUMBER EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, PHONE NUMBER IS AS FOLLOWS: (B)(6). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACURING NARRATIVE: OTHER TEXT: THE RETURNED DEVICE WAS INVESTIGATED. THE DEVICE BATTERY WAS NOT RECORDING THE FULL CHARGE CAPACITY AS IT DEPLETED QUICKLY AND SHUT DOWN WITH A LOW BATTERY ERROR MESSAGE. THE DEVICE WAS THEN UNABLE TO BE POWERED BACK ON USING THE BATTERY. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: G51 4TF. INITIAL REPORTER PHONE NUMBER EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, PHONE NUMBER IS AS FOLLOWS: 0141 452 3286.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE POWERED OFF DURING USE AND WON'T POWER BACK ON. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE POWERED OFF DURING USE AND WON'T POWER BACK ON. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186879 KIT, RAD-97 PULSE CO-OXIMETER MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI MASIMO - 15750 ALTON PKWY 27572 00843997012317

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown