BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MP50

    MDR report key: 21992303 · Received May 9, 2025

    Report

    Report Number
    9610816-2025-000397
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 21, 2025
    Report Date
    July 21, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSI
    PMA / PMN Number
    K151681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS REMOTE CLINICAL PERSONNEL SPOKE WITH THE CUSTOMER. IT WAS REPORTED THAT ON (B)(6) 2025 AT APPROXIMATELY 1600 HOURS IN INTERMEDIATE ICU ON THE 7TH FLOOR, THE PATIENT HAD A DESATURATION (DESAT) EVENT AND HAD TO BE MOVED TO THE ICU FOR HIGHER LEVEL OF CARE. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR ONSITE SERVICE AND FUNCTIONAL TESTING OF THE ALARMS REVEALED NO ANOMALIES. THE ISSUE WAS ESCALATED TO A PHILIPS PRODUCT SUPPORT ENGINEER (PSE). THE PSE DETERMINED THAT PIC CLASSIC SW REV N.X DOES NOT HAVE THE AVAILABLE CLINICAL AUDIT LOG OPTION TO CAPTURE "SPO2 ALARMS THAT HAD BEEN TURNED OFF." THE LOG FILES WERE REVIEWED BY A PHILIPS MEDICAL SAFETY MANAGER. WHILE IT IS UNKNOWN IF THE ALARMS WERE TURNED OFF AT THE TIME OF THE EVENT, LOG ENTRIES DISPLAY SUCCESSFUL DESAT ALARMING AT 16:50:50 ON (B)(6) 2025. 15:26:12.997 (B)(6) 2025 : DATASERVER 706A, LBN 204, ALARMS SUSPENDED. 15:27:14.465 (B)(6) 2025 : DATASERVER 706A, LBN 204, ALARMS NOT SUSPENDED. 15:27:23.887 (B)(6) 2025 : SDPROCESS 706A RED ALARM SOUND -BED. 15:27:25.106 (B)(6) 2025 : SDPROCESS 706A ALARM !!!ECG LEADS OFF. 15:30:06.575 (B)(6) 2025 : DATASERVER 706A, LBN 204, ALARMS SUSPENDED. 15:31:08.044 (B)(6) 2025 : DATASERVER 706A, LBN 204, ALARMS NOT SUSPENDED. 16:42:18.169 (B)(6) 2025 : SDPROCESS 706A RED ALARM SOUND -BED. 16:42:19.387 (B)(6) 2025 : SDPROCESS 706A ALARM DESAT 72 < 85. 16:42:19.387 (B)(6) 2025 : SDPROCESS 706A RED ALARM SOUND -BED. 16:50:49.419 (B)(6) 2025 : SDPROCESS 706A RED ALARM SOUND -BED. 16:50:50.497 (B)(6) 2025 : SDPROCESS 706A ALARM DESAT 75 < 85. 16:50:51.950 (B)(6) 2025 : SDPROCESS SILENCED 706A *** DESAT 75 < 85. THE ISSUE WAS NOT CONFIRMED AS THE INVESTIGATION FOUND NO EVIDENCE OF MALFUNCTION. THE CUSTOMER IS ADVISED TO CONSIDER UPGRADING FROM THE CLASSIC PIIC TO PIC IX, WHICH HAS A BROADER CATALOGUE OF EVENTS THAT CAN BE CAPTURED. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    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. D4: THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT DESATURATED AND WAS TRANSFERRED TO ICU; HOWEVER, IT WAS SUSPECTED THE SPO2 ALARMS HAD BEEN TURNED OFF. THE CUSTOMER REQUESTED ASSISTANCE DETERMINING WHETHER THE SPO2 ALARM WAS TURNED OFF BY A USER AT THE BEDSIDE MONITOR. FUNCTIONAL TESTING OF THE ALARMS REVEALED NO ANOMALIES. GOOD FAITH EFFORT ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998349 INTELLIVUE MP50 INTELLIVUE MP50 DSI PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 862116

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Life Threatening