BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20350110 · Received October 2, 2024

    Report

    Report Number
    9610816-2024-00669
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 12, 2024
    Report Date
    November 1, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    0088483812277
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE PROVIDED LOGS WERE REVIEWED BY PHILIPS A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS) AND THE FOLLOWING DETERMINATION WAS PROVIDED. THE LOG INCLUDES THE DATE IN QUESTION, (B)(6) 2024 AND THE BED ED-20 AND STARTS AT 17:03:26 WITH SPO2 85<88, WHICH ENDS AT 17:03:32, THIS IS FOLLOWED BY AN APNEA ALARM AT 17:10:10, WHICH ENDS AT 17:25:05. THERE WAS SOMEONE AT THE BEDSIDE THAT ACKNOWLEDGED THE ALARMS AT 17:25:06. YELLOW **SPO2 LOW ALARMS CONTINUE TO BE GENERATED THROUGHOUT THE STATED TIME PERIOD AT 17:15:50, 17:21:14, 17:21:34, 17:24:19, 17:27:30, 17:28:25, 17:36:17, 17:39:18, 17:45:34, DATA CONTINUES IN THE AUDIT LOG UNTIL 18:59:56 FOR BED ED-20. PER THE INVESTIGATION, THE ALARM SETTINGS ARE RED ALARMS VISUALLY LATCHED, YELLOW ALARM NON-LATCHED VISUALLY, RED OR YELLOW NON-LATCHED AUDIBLY. WHICH MEANS, RED ALARMS KEEP THE ALARM BANNER ON THE PIC IX AND THE BEDSIDE MONITOR BUT THE SOUND ONLY PLAYS AS LONG AS THE CONDITION IS ACTIVE. RED ALARMS MUST BE ACKNOWLEDGED FOR THE VISUAL ALARM BANNER TO GO AWAY BUT THE SOUND ONLY PLAYS WHILE THE ACTUAL ALARM IS ACTIVE. THE YELLOW ALARMS ARE CONFIGURED TO BE BOTH AUDIBLY AND VISUALLY NON LATCHED WHICH MEANS THAT THE YELLOW BANNER AND ALARM SOUND STOPS AS SOON AS THE ALARM IS NO LONGER ACTIVE. IN THIS CONFIGURATION, YELLOW SPO2 ALARMS WERE SET TO 88. ONCE THE PATIENT REACHED A O2 SATURATION GREATER THAN 88 THE ALARM SOUND STOPPED AND THE ALARM BANNER WENT AWAY WITHOUT USER INTERACTION. AFTER REVIEW OF THE AVAILABLE INFORMATION, THE PIC IX IS WORKING AS DESIGNED AND AS CONFIGURED. THE AUDIBLE ALARM STOPPING AT THE PIC IX IS DUE TO THE RED AND YELLOW NON-LATCHED AUDIBLE ALARM CONFIGURATION SETTING OF THE BEDSIDE MONITOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE WAS NOT ALARMING AT THE PATIENT INFORMATION CENTER IX AND CANCELED ITSELF OUT. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352184 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866389 0088483812277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown