BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 18943508 · Received March 20, 2024

    Report

    Report Number
    1218950-2024-00205
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 26, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K153702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND THE CUSTOMER ALLEGED THAT THERE WAS A RED THAT DID NOT ALARM. THE RSE REMOTE INTO THE AUDIT LOG AND ANALYZED THE AUDIT LOG FOR (B)(6) 2024 ON 08:25 A.M. THE RSE NOTED THE FOLLOWING: TACHYCARDIA (XTACHY) ALARM GENERATED ON SUR2 AND OVR4 AT 08:24:57 AND ACKNOWLEDGED AT 08:25:19 AT (B)(4). (B)(6) 2024 08:27:27 346 * AFIB GENERATED AT 08:27:07 PIC IX: (B)(4). (B)(6) 2024 08:27:27 346 * AFIB GENERATED AT 08:27:07 PIC IX: (B)(4). (B)(6) 2024 08:27:27 346 * IRREGULAR HR ENDED PIC IX: (B)(4). (B)(6) 2024 08:27:27 346 * IRREGULAR HR ENDED PIC IX: (B)(4). (B)(6) 2024 08:27:15 346 * NURSE CALL GENERATED AT 08:26:55 PIC IX: (B)(4). (B)(6) 2024 08:27:15 346 * NURSE CALL GENERATED AT 08:26:55 PIC IX: (B)(4). (B)(6) 2024 08:26:27 346 ACKNOWLEDGE (B)(4). (B)(6) 2024 08:25:59 346 * IRREGULAR HR GENERATED AT 08:25:39 PIC IX: (B)(4). (B)(6) 2024 08:25:59 346 * IRREGULAR HR GENERATED AT 08:25:39 PIC IX: (B)(4). (B)(6) 2024 08:25:19 346 ACKNOWLEDGE (B)(4). (B)(6) 2024 08:25:17 346 *** XTACHY 144> 140 GENERATED AT 08:24:57 PIC IX: (B)(4). (B)(6) 2024 08:25:17 346 *** XTACHY 144> 140 GENERATED AT 08:24:57 PIC IX: (B)(4). (B)(6) 2024 08:25:17 346 * HR 137 > 120 ENDED PIC IX: (B)(4). (B)(6) 2024 08:25:17 346 * HR 137 > 120 ENDED PIC IX: (B)(4). (B)(6) 2024 08:25:16 346 * HR 137 > 120 GENERATED AT 08:24:56 PIC IX: (B)(4). (B)(6) 2024 08:25:16 346 * HR 137 > 120 GENERATED AT 08:24:56 PIC IX: (B)(4). (B)(6) 2024 08:22:00 346 * HR 123 > 120 ENDED PIC IX: (B)(4). (B)(6) 2024 08:22:00 346 * HR 123 > 120 ENDED PIC IX: (B)(4). (B)(6) 2024 08:21:57 346 ACKNOWLEDGE (B)(4). THE RSE EXPLAINED ALARMS VS. ALARM NOTIFICATIONS TO THE CUSTOMER AND SENT PICTURE OF AUDIT LOG, ALARM LATCHING AND ALARM CHAINING TO THE CUSTOMER. THE RSE INFORMED THE CUSTOMER THAT THE ALARM WAS ACKNOWLEDGED IN "TELE ROOM" AND FOR THIS REASON THE SOUND WAS NOT GENERATED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. ANALYSIS WAS PERFORMED AND INVESTIGATION HAS BEEN COMPLETED. THE ENGINEER EXPLAINED ALARMS VS. ALARM NOTIFICATIONS TO THE CUSTOMER. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RED ALARM WAS SEEN AND NOT HEARD. 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
    1985830 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown