BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PATIENT MONITORING BEDSIDE MONITOR

    MDR report key: 16153032 · Received January 12, 2023

    Report

    Report Number
    9610816-2022-00637
    Event Type
    Death
    Date Received
    January 12, 2023
    Date of Event
    September 30, 2022
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. REPORTER PHONE # (B)(6). REPORTING INSTITUTION PHONE # (B)(6).

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : NO RESPONSE TO ANY COMMUNICATION ATTEMPTS WERE RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON SEPTEMBER 30 A PATIENT WITH A TEMPORARY PACEMAKER WENT INTO CARDIAC ARREST AND THE PATIENT MONITORING SYSTEM FAILED TO ALARM WHICH RESULTED IN THE PATIENTS DEATH.

    Description of Event or Problem · 0

    STATEMENT OF THE REPORTED PROBLEM: THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS QUALITY AND REGULATORY PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE UNKNOWN BEDSIDE PATIENT MONITOR INDICATING THAT THE DEVICE DID NOT ALARM WHEN PACING OCCURRED. THUS, THE HEALTHCARE PROVIDERS WERE UNAWARE OF THE PATIENT¿S CONDITION. SUBSEQUENTLY, THE PATIENT SUFFERED R ON T VENTRICULAR FIBRILLATORY ARREST. THE HEALTHCARE PROVIDERS ATTEMPTED TO RESUSCITATE THE PATIENT, BUT THEY DIED AS A RESULT OF THE EVENT. FUNCTIONAL TESTING/SERVICE REPAIR/TECHNICAL INVESTIGATION: THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: GOOD FAITH EFFORT ATTEMPT COMPLETED TO GATHER ADDITIONAL DETAILS REGARDING THE EVENT, FUNCTIONAL TESTING RESULTS, AND TO OBTAIN THE EVENT LOGS, BUT NO ADDITIONAL INFORMATION COULD BE PROVIDED. RESULTS OF FUNCTIONAL TESTING COULD NOT BE CONFIRMED. CONFIRMATION: BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE CONFIRMED. IT¿S UNKNOWN IF THE REPORTED PROBLEM WAS CONFIRMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED TO CONFIRM IF A WORK ORDER WAS CREATED FOR THE ISSUE. ADDITIONALLY, THE CUSTOMER INDICATED NO ADDITIONAL INFORMATION WAS AVAILABLE. FURTHER ACTION DECISION: BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. RISK ANALYSIS: A REVIEW OF THE RISK MANAGEMENT FILE WAS PERFORMED AND IT HAS BEEN DETERMINED THAT THE ALLEGATION IS REPORTABLE BECAUSE THE DEVICE MAY HAVE CONTRIBUTED TO THE DEATH OF THE PATIENT. CLINICAL HARM REVIEW: THIS EVENT IS ASSESSED AS POSSIBLY RELATED TO THE PRODUCT PROBLEM WITH THE UNKNOWN PATIENT BEDSIDE MONITOR WAS REPORTED TO HAVE FAILED TO ALARM AND ALERT THE CAREGIVER OF INAPPROPRIATE PACING WHICH EVENTUALLY LED TO ¿R ON T PHENOMENON AND SUBSEQUENT IRREVERSIBLE VENTRICULAR FIBRILLATION." HOWEVER, THE SPECIFIC DETAILS OF THIS EVENT REMAIN UNKNOWN AT THE TIME OF THIS REVIEW. FURTHER, THIS EVENT OF FAILURE TO ALARM IS ASSESSED AS LABELED AND PREDICTED. NO FURTHER ACTION IS REQUIRED. TRENDING STATEMENT: THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. CLOSURE & PRODUCT DISPOSITION: IT IS UNKNOWN IF THE DEVICE IS BACK IN SERVICE DUE TO INSUFFICIENT INFORMATION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528753 UNKNOWN PATIENT MONITORING BEDSIDE MONITOR UNKNOWN PATIENT MONITORING BEDSIDE MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH UNK013-BEDSIDE MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Unknown Death