BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 13087658 · Received December 27, 2021

    Report

    Report Number
    1218950-2021-11212
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    December 3, 2021
    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
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL SPECIALIST (RCS) SPOKE WITH THE CUSTOMER. THE CUSTOMER CLINICAL MANAGER INDICATED THAT AT 12:04 ON (B)(6) 2021 ON NICU BED 607NSKB, THE NURSE NOTICED THE PATIENT'S SECTOR SHOWED THE RED SPO2 DESAT ALARM TEXT (VISUAL) BANNER BUT THE SECTOR RED AUDIBLE ALARM WAS NOT GENERATED/ANNOUNCED. THE NURSE THEN WENT TO CHECK ON THE NICU PATIENT, AND FOUND THE NEONATE PATIENT WAS IN DISTRESS AND CLAIMS THE BABY HAD TURNED BLUE. THE PATIENT WAS TRANSFERRED TO A DIFFERENT BED# 604NSBK. PER THE CLINICAL MANAGER, THE NURSE CLAIMS SHE DID NOT SILENCE OR ACKNOWLEDGE THE ALARMS. THE CLINICAL MANAGER REQUESTED LOG REVIEW TO DETERMINE IF THE ALARM WAS SILENCED. THE RCS PROVIDED THE CLINICAL MGR. THE INSTRUCTION ON HOW TO VIEW THE PATIENT'S CLINICAL AUDIT LOG EVENTS FOR THIS PATIENT. THE CLINICAL AUDIT SHOWED THE PATIENT SPO2 DESAT ALARM WAS GENERATED AND ACKNOWLEDGED/SILENCED. THE CUSTOMER CLINICAL USER DID NOT ALLEGE THAT THE PIC IX CONTRIBUTED TO THE NEONATE DISTRESS. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE; THE USER SILENCED THE ALARM. THE RCS PROVIDED INFORMATION WAS PROVIDED TO THE CUSTOMER TO RESOLVE THE ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PIIC FAILED TO ALARM FOR A (B)(6) PATIENT. THE PATIENT WAS FOUND BLUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT INFORMATION CENTER IX (PIC IX) FAILED TO ALARM FOR A 35 WEEK OLD PATIENT. THE PATIENT WAS FOUND BLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987212 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 245 DA Male Required Intervention