BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8, HORIZONTAL

    MDR report key: 7521047 · Received May 16, 2018

    Report

    Report Number
    2031172-2018-00286
    Event Type
    Death
    Date Received
    May 16, 2018
    Date of Event
    December 4, 2015
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND IT WAS DETERMINED THAT THE DEVICE MET ALL RELEASE CRITERIA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED: "THE FOLLOWING INFORMATION WAS ALLEGED IN A COMPLAINT FILED BY PLAINTIFF (B)(6), ET-AL, (REFERENCE #(B)(6)) RELATED TO MASIMO¿S RAD 8 PULSE OXIMETER: ¿ON OR BEFORE THE (B)(6) 2015, [THE PATIENT] REQUIRED A MASIMO RAD 8 PULSE OXIMETER WHICH FAILED.¿ ¿SAID DESIGN, MANUFACTURE, ASSEMBLY, INSTALLATION, REPAIR, MODIFICATION, MAINTENANCE, SERVICING, SALE AND/OR DISTRIBUTION WAS PERFORMED BY DEFENDANTS, AT HOME MEDICAL, MASIMO, ABC CORPORATION, XYZ PARTNERSHIP (REPRESENTING A SERIES OF FICTITIOUS NAMES), IN A NEGLIGENT, RECKLESS AND CARELESS MANNER AS A RESULT OF WHICH PLAINTIFF [THE PATIENT], SUSTAINED SERIOUS, PAINFUL AND PERMANENT INJURIES AND DEATH.¿ ¿AS A MATTER OF FACT, SAID MASIMO RAD 8 PULSE OXIMETER AND/OR ITS COMPONENTS WERE NOT DESIGNED, MANUFACTURED, ASSEMBLED, INSTALLED, REPAIRED, MODIFIED, MAINTAINED, SERVICED, SOLD AND/OR DISTRIBUTED IN A PROPER MANNER, FIT, SAFE AND SUITABLE FOR THE USE INTENDED, AS A RESULT OF WHICH PLAINTIFF SUSTAINED THE DAMAGES AND LOSSES REFERRED TO ABOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360470 RAD-8, HORIZONTAL OXIMETER DQA MASIMO - 40 PARKER 9190

    Patients

    Seq Age Sex Outcome Treatment
    1 Death