BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)

    MDR report key: 24313302 · Received February 11, 2026

    Report

    Report Number
    9610816-2026-100262
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 11, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DQA
    UDI-DI
    00884838082595
    PMA / PMN Number
    K032979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED BY REMOTE SERVICE PERSONNEL. THE REMOTE SUPPORT ENGINEER (RSE) TALKED TO THE CUSTOMER AND CONFIRMED THE DETAILS ABOUT THE CABLES USED. THE CUSTOMER REPORTED THAT THEY DID NOT SEE ISSUE LIKE THIS WITH ADAPTER CABLES MANUFACTURED AT ANOTHER MANUFACTURER DATE. THE RESULTS OF THE ANALYSIS WERE THAT THE CUSTOMER WAS ADVISED TO REPLACE THE DEFECTIVE CABLES WITH NEW ONE. BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM WAS A DEFECTIVE SPO2 ADAPTER CABLE. THE ISSUE WAS RESOLVED BY ADVISING THE CUSTOMER TO REPLACE THE DEFECTIVE CABLE WITH NEW ONE FROM ANOTHER MANUFACTURER DATE AND LOT/BATCH. E1: REPORTING INSTITUTION PHONE #: (B)(6). E1: REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADAPTER CABLE HAS INTERMITTENT ISSUES WHERE THE SATURATION MONITOR DISPLAYS A LOW OR HIGH HEART RATE VALUES (BETWEEN 20¿220) WHILE SPO2 VALUE IS DISPLAYED CORRECTLY. BUT WHEN ECG IS CONNECTED, THE HEART RATE LEVEL IS NORMAL. THE DEVICE WAS IN CLINICAL USE. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373201 SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN) SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN) DQA PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN) 00884838082595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown