BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 13026105 · Received December 17, 2021

    Report

    Report Number
    1218950-2021-11194
    Event Type
    Death
    Date Received
    December 17, 2021
    Date of Event
    December 14, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND FOUND THAT A STUDENT WAS IN ROOM 211F AS THE PATIENT HAD SPO2 SATURATION BELOW <50%. THE STUDENT RAN OUT OF THE ROOM TO INFORM THE NURSE AND THE NURSE IMMEDIATELY WENT TO ROOM 211F. AT THIS POINT, THE BRADYCARDIA ALARM WENT ON. A SECOND STAFF NURSE STATED THAT THE ROOM 211F BRADYCARDIA ALARM DID NOT DISPLAY IN ROOM 218 VIA BED TO BED (CARE GROUP) MONITORING. A PHILIPS PRODUCT SUPPORT REPRESENTATIVE (PSR) REVIEWED THE PIC IX SERVICE LOGS FOR THIS EVENT. THE LOGS INDICATED THAT THE DEVICE/BED WAS BEING OVERVIEWED IN 214F AND 215F FREQUENTLY. A SESSION FROM 10800017 TO 215F WAS OPENED AT 8:03:27 AND REMAINED OPEN. A SERIES OF ALARM RECORDINGS WERE GENERATED FROM BED 211F STARTING AROUND 8:04:40, CONTINUING AT LEAST UNTIL 8:21, WHICH ARE ALSO IN THE ALARMS RECORDINGS AND AUDIT LOGS SHOWN BELOW AND/ OR IN ATTACHED CUSTOMER LETTER. THE DEVICE WAS PLACED IN STANDBY IN THE ROOM AT 8:23 UNTIL 9:12. MR. (B)(6) FROM THE FACILITY CONFIRMED THAT AN ALARM FROM BED 219 WAS DISPLAYED ON THE ROOM 218 MONITOR AT THE TIME OF THE INCIDENT. ADDITIONALLY, ROOM 211 WAS DISPLAYED IN THE UPPER ALARM FIELD WITH RED FLAGS. BASED ON THIS INFORMATION, THE POP-UP OF ROOM 219 WAS OPEN AND ACTIVE ON THE ROOM 218 MONITOR AT THE TIME OF THE REPORTED EVENT AND THIS SUPPRESSED THE BED 211 CARE GROUP POP-UP NOTIFICATION. A PHILIPS FIELD SERVICE ENGINEER WAS DISPATCHED FOR ONSITE SERVICE. LOGS WERE RETRIEVED AND SENT FOR CLINICAL ASSESSMENT. THE FSE EXCHANGED THE SURVEILLANCE MACHINE EKPHIZIMC AND THE DEVICE WAS SENT TO THE TESTING LAB. FOLLOWING TWO WEEKS OF TESTING, NO TROUBLE HAS BEEN IDENTIFIED. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE. THE POP-UP OF ROOM 219 WAS OPEN AND ACTIVE ON THE ROOM 218 MONITOR AT THE TIME OF THE REPORTED EVENT AND THIS SUPPRESSED THE BED 211 CARE GROUP POP-UP NOTIFICATION. ALTHOUGH THE BED 211 CARE GROUP POP-UP ALARM WAS SUPPRESSED AT SOME BEDSIDES, THE PIX IX SERVICE LOGS INDICATED THAT THE DEVICE/BED WAS BEING OVERVIEWED IN 214F AND 215F, ALARMS WERE RECORDED AS CONFIGURED. ALARMS WERE ALSO AVAILABLE AT THE INFORMATION CENTER AND THE BEDSIDE MONITOR AND WERE RESPONDED TO IN THE ROOM BY THE CLINICIAN. BASED ON PHILIPS¿ INVESTIGATION, THE PIC IX DEVICE IS OPERATING AS DESIGNED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED: ON (B)(6) 2021 AT AROUND 8:15 A.M. [LATER UPDATED TO 8:00 AM], A PATIENT IN BED 211F REQUIRED RESUSCITATION ON THE INTERMEDIATE CARE (IMC) WARD. ACCORDING TO THE USER IN ROOM 218, THE ALARM WAS NOT DISPLAYED ON BOTH MONITORS (218F AND 218T) VIA BED-TO-BED OVERVIEW/POP-UP. THE PATIENT WAS REQUIRED TO BE RESUSCITATED AND CONSEQUENTLY DIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED: ON (B)(6) 2021 AT AROUND 8:15 A.M. [LATER UPDATED TO 8:00 AM], A PATIENT IN BED (B)(6) REQUIRED RESUSCITATION ON THE IMC WARD. ACCORDING TO THE USER IN ROOM (B)(6), THE ALARM WAS NOT DISPLAYED ON BOTH MONITORS ((B)(6)) VIA BED-TO-BED OVERVIEW/POP-UP. THE PATIENT WAS REQUIRED TO BE RESUSCITATED AND CONSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924609 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death