BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIBP CUFFS

    MDR report key: 23988391 · Received January 7, 2026

    Report

    Report Number
    9610816-2026-100017
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 23, 2025
    Report Date
    February 20, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    OED
    UDI-DI
    00884838114784
    PMA / PMN Number
    K071885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS PRODUCT INDUSTRIALIZATION ENGINEER (PIE) AND REGULATORY AFFAIRS SPECIALIST (RAS) REVIEWED THE AVAILABLE DATA AND CONFIRMED THAT THE WORD CUFF WAS MISSING FROM THE PRODUCT; THIS AFFECTED THE GRAPHIC PRINTING ON THE CUFF BODY FOR THIS ONE DEVICE. 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 PRINTING ISSUE ON THIS DEVICE. THE ISSUE WAS BEING RESOLVED BY A REVIEW ALL CUFFS' CDLMS (GENTLE LS-200080, EASY LS-200081, COMFORT LS-200078, NEONATAL LS-200079, AND AIR HOSES LS-200082) TO CHECK IF THERE ARE MARKINGS TO BE ADDED TO THE CDLM. 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. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

    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

    PHILIPS RECEIVED A COMPLAINT ON AN EASY CARE CUFF 1 HOSE, LARGE ADULT XL INDICATING THAT THE CENTRAL COE MV (CENTER OF EXCELLENCE MARKET VERIFICATION) PERFORMED A VERIFICATION OF LABELING AND FOUND A LACK OF THE FULL NAME OF THE DEVICE ON THE PRODUCT, THE LABEL WORD "CUFF" MISSING, AND A LACK OF THE LEGAL MANUFACTURER'S ADDRESS AND INDICATOR. THIS WAS NOTED DURING INSPECTION; NO ADVERSE EVENT OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51463 NIBP CUFFS ANTIMICROBIAL BLOOD PRESSURE CUFF OED PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EASY CARE CUFF,1 HOSE,LRG ADULT XL (1) 00884838114784

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown