BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREEVENT REL A.0

    MDR report key: 7358388 · Received March 21, 2018

    Report

    Report Number
    1218950-2018-02697
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    February 17, 2018
    Report Date
    February 21, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MSX
    PMA / PMN Number
    K142935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PHILIPS BRADY ALERT FROM BED 562 ON (B)(6) 18 AT 18:06 (6:06 PM) WAS NOT SENT TO THE CAREEVENT END DEVICE. THE NURSE AND NURSE BUDDY DID NOT RECEIVE THE PAGE IN QUESTION AND THE PATIENT BECAME BRADYCARDIC, HYPOTENSIVE & STOPPED BREATHING AND REQUIRED EMERGENT CARE. THE PATIENT REQUIRED RESUSCITATION AND SUBSEQUENTLY SURVIVED. PER PRODUCT SUPPORT ENGINEER, IN RESPONSE TO THE "PATIENT INVOLVEMENT" EVENT THAT OCCURRED AT (B)(6) MEDICAL CENTER ON (B)(6) 18 @ 1806, PHILIPS CONDUCTED AN INVESTIGATION OF THE PHILIPS SOFTWARE, AND CONCLUDED THAT THE SYSTEM FUNCTIONED AS DESIGNED. THE INVESTIGATION FOUND THAT ONE PHILIPS ALERT MESSAGE WAS DELIVERED FROM PHILIPS PIICIX BED "562 SMF" TO CAREEVENT ON (B)(6) 18 @ 18:06. THIS ALERT MESSAGE A RED SPO2 TEXT="DESAT 82 < 85" WAS ASSIGNED TO LEVEL 1 CAREEVENT ASSIGNMENT NURSE=(B)(6) AND TO LEVEL 2 CAREEVENT ASSIGNMENT BUDDY NURSE= (B)(6) WITH LEVEL 3 CE ASSIGNMENT ESCALATION SET UP. BOTH ASSIGNED CAREGIVERS HAD NO END DEVICES LOGGED IN AT THE TIME OF THE ISSUE SO THE ALERT WAS NOT DELIVERED TO AN END DEVICE DUE TO THIS REASON. THE CAREEVENT SYSTEM IS CONSIDERED AS A FACTOR IN THE ADVERSE EVENT ALTHOUGH THE CAREEVENT SYSTEM WAS WORKING AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHILIPS BRADY ALERT FROM BED 562 ON (B)(6) 2018 AT 18:06 (6:06 PM) WAS NOT SENT TO THE CAREEVENT END DEVICE. THE NURSE DID NOT RECEIVE THE PAGE IN QUESTION AND THE PATIENT BECAME BRADYCARDIC, HYPOTENSIVE & STOPPED BREATHING AND REQUIRED EMERGENT CARE. THE PATIENT REQUIRED RESUSCITATION AND SUBSEQUENTLY SURVIVED. IT IS CONSIDERED A SERIOUS INJURY IF THE PATIENT REQUIRES EMERGENT CARE. PER THE CUSTOMER, ON SATURDAY THE PATIENT IN ROOM (B)(6), WHO WAS A POST OP DAY 1 CABG (CORONARY ARTERY BYPASS GRAFT) WAS DOING WELL: EXTUBATED IN THE AM, IABP (INTRA-AORTIC BALLOON PUMP) OUT IN THE AFTERNOON, STABLE VITAL SIGNS. THE CAREGIVER WENT TO HANG AN IV DOWN THE HALL IN THEIR OTHER PATIENT¿S ROOM, AND THE PATIENT BECAME BRADYCARDIC, HYPOTENSIVE AND STOPPED BREATHING. THE PIIC RED ALARM WENT OFF, BUT THE CAREGIVER'S PAGING PHONE DIDN¿T, ALTHOUGH THEY HAD LOGGED INTO THE PAGING SYSTEM AT LEAST TWICE DURING THE DAY. NURSE SAW IT ON THE MONITOR ON B WING AND RAN OVER, AND NURSE EVENTUALLY WAS ABLE TO GET THERE AS WELL, BEING BUSY NEXT DOOR. THEY WERE BUDDIED, AND NURSE SAID HER PHONE DIDN¿T ALARM EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200856 CAREEVENT REL A.0 CARDIAC MONITOR MSX PHILIPS MEDICAL SYSTEMS 866435

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening