BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 14603626 · Received June 6, 2022

    Report

    Report Number
    1218950-2022-00454
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    May 11, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL SPECIALIST (RCS) SPOKE WITH THE CUSTOMER. THE RCS IDENTIFIED THAT THE ALARM LIMITS WERE SET TOO WIDE. EVALUATION OF THE ALARM LIMITS FOUND THAT CURRENT VALUES WERE 85 FOR SPO2 LOW AND 80 FOR DESATURATION (DESAT). THE DESIRED SPO2 LOW LIMIT IS 90 AND THE DESIRED DESAT LOW LIMIT IS 85. THE NURSE MANAGER NO LONGER ALLEGED A PHILIPS PRODUCT MALFUNCTION OR SAFETY ISSUE. SHE STATED THAT DURING COVID THEY ACQUIRED SOME 117 MONITORS AND WAS NOW PLANNING TO RE-EVALUATE AND CHANGE ALARM LIMITS ON EVERY MONITOR. A PHILIPS TECHNICAL CONSULTANT (TC) WAS DISPATCHED. THE TC VERIFIED THAT THE DESAT ALARM LIMITS WERE SET TO 80 AND THE DEVICE ALARMED AS EXPECTED. THE TC VERIFIED THAT THE DESAT ALARM LIMIT WORKING BY GENERATING SP02 UNDER 85 AND WAITING 10 SECONDS. THE MP70 BEDSIDE MONITOR AND PIC IX OPERATED AS EXPECTED AND GENERATED A RED ALARM FOR DESAT <85. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE. THE RCS PROVIDED INFORMATION TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS HARMED ON (B)(6) 2022 AT 0930 WHEN THE PATIENT INFORMATION CENTER IX (PIC IX) DID NOT ALARM. THE PATIENT REQUIRED OXYGEN THERAPY. THE DEVICE WAS IN YOUR USE AT TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158553 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention