BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP90

    MDR report key: 19475628 · Received June 6, 2024

    Report

    Report Number
    9610816-2024-00316
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 23, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSI
    UDI-DI
    00884838000223
    PMA / PMN Number
    K151681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) REVIEWED THE MP90 ALARMS FOR ROOM 805 AT PIIC CLASSIC AND THERE WERE NO RED OR YELLOW ALARMS BETWEEN 1619 AND 1744. THE RSE DISPATCHED A PHILIPS TECHNICAL CONSULTANT (TC) ONSITE TO PULL THE LOGS. THE RSE STATED THE DEVICE IS AT END OF LIFE (EOL) IT MAY RETURN LIMITED INFORMATION. THE TC EVALUATED THE LOGS AND DEVICE; HOWEVER, UNABLE TO DUPLICATE THE CUSTOMER'S ISSUE. THE DEVICE WAS OPERATING AS EXPECTED AND ALL TESTING PASSED. PHILIPS REQUESTED THE LOGS TO BE FURTHER EVALUATED BY AN INTERNAL PRODUCT SUPPORT ENGINEER (PSE). THE PSE REPORTED THERE WOULD NOT BE YELLOW AND INOP ALARMS LOGGED IN CLASSIC PIIC LOGS ; THEREFORE, PHILIPS COULD NOT CONFIRM OR DENY THE ALLEGATION THERE WERE NO YELLOW ALARMS AT THE TIME OF EVENT, CLASSIC PIIC ONLY LOGS RED ALARMS. THERE WERE NO RED ALARMS, BUT THERE WAS THE ECG LEADS OFF WHICH OCCURRED JUST BEFORE THIS PERIOD THAT COULD HAVE PREVENTED A RED RHYTHM ALARM. AT 16:17:46, A !!! ECG LEADS OFF ALARM WAS LOGGED, AND IT ESCALATED TO A RED ALARM, WHICH IS WHY IT WAS LOGGED. THERE WAS NO WAY OF TELLING HOW LONG THE ALARM WAS ACTIVE. THE NEXT ALARM WAS AT 18:28:58 FOR APNEA. THE PHILIPS PSE REQUESTED FOR VITAL TREND DATA AND STRIPS THAT CAN SHOW VALUES ON THEM AND WHY THE CUSTOMER SHOULD HAVE RECEIVED AN ALARM. THE TC MENTIONED RECORDING STRIPS AND VITAL TREND DATA WERE NOT MADE AVAILABLE, THE EVENT OCCURRED MAY 9, 2024 ABOUT 17:11 DATE (B)(6) 2024, TIME 16:19:09, ACTION DATASERVER 805, LBN 119, ALARMS SUSPENDED DATE (B)(6) 2024, TIME 16:17:39, ACTION DATASERVER 805, LBN 119, ALARMS NOT SUSPENDED DATE (B)(6) 2024, TIME16:17:44, ACTION SDPROCESS 805 RED ALARM SOUND -BED. DATE (B)(6) 2024, TIME16:17:46, ACTION SDPROCESS 805 ALARM !!! ECG LEADS OFF. DATE (B)(6) 2024, TIME16:17:51, ACTION DATASERVER 805, LBN 119, ARRH ALARMS OFF. DATE (B)(6) 2024, TIME16:17:58, ACTION DATASERVER 805, LBN 119, ARRH ALARMS ON. DATE (B)(6) 2024, TIME18:28:58, ACTION SDPROCESS 805 RED ALARM SOUND -BED. DATE (B)(6) 2024, TIME18:28:58, ACTION SDPROCESS 805 ALARM *** APNEA. BASED ON THE INFORMATION AVAILABLE IN THE CASE, BY THE PHILIPS RSE, TC AND THE LOGS PROVIDED, THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE CONFIRMED. WITH THE INFORMATION PROVIDED, PHILIPS CANNOT CONFIRM OR DENY THE DEVICE DID NOT ALARM WHEN IT SHOULD HAVE ALARMED. AT ANY TIME, THERE WAS NO DISCONNECTION BETWEEN THE CENTRAL STATION AND THE DEVICE. THE DEVICE NEVER WENT OFFLINE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CENTRAL STATION STOPPED ALARMING WHILE THE PATIENT WAS HAVING EVENT (PULSE AUX WENT TO 20%). THERE SHOULD HAVE BEEN AN ALARM SENT TO THE PIC FROM THE M90.THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CENTRAL STATION STOPPED ALARMING WHILE THE PATIENT WAS HAVING EVENT (PULSE AUX WENT TO 20%) .THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2798 INTELLIVUE MP90 INTELLIVUE MP90 DSI PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 862452 00884838000223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown