BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIA

    MDR report key: 24710005 · Received March 30, 2026

    Report

    Report Number
    3042177665-2026-000016
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 22, 2026
    Report Date
    March 27, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    UDI-DI
    884838095083
    PMA / PMN Number
    K043147
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT DID NOT MALFUNCTION AND THE CAUSE OF THE REPORTED INCIDENT WAS A USE ERROR. THE PATIENT'S LEFT HAND WAS PINCHED DURING VERTICAL MOVEMENT OF THE PATIENT SUPPORT CONNECTING THE TABLETOP. X-RAY OF LEFT HAND REPORTED AS AN UN DISPLACED FRACTURE OF THE TUFT OF DISTAL PHALANX OF THE MIDDLE FINGER. THE ROOT CAUSE OF THIS FINGER PINCHING RELATED INCIDENT IS USE ERROR. THE FINGER PINCHING RELATED INCIDENT COULD HAVE OCCURRED DUE TO MISUSE BY A PERSON WHO WAS EITHER UNTRAINED AND UNSUPERVISED (VIOLATION OF THE IFU AND LOCAL SAFETY PROCEDURES), OR BY A TRAINED EMPLOYEE WHO WAS NOT FOLLOWING THE IFU AND/OR WAS ALSO IGNORING THE WARNING LABELS (CONSCIOUS DECISION TO ACT IN OPPOSITION TO TRAINING AND/OR NORMAL USE INSTRUCTIONS). IN ADDITION, NO ARM BOARDS (PROTECTIVE MEASURES TO PREVENT FINGER PINCHING WHICH ARE PART OF THE MR SYSTEM BILL OF MATERIAL (BOM)) WERE USED AT THE TIME THE INJURY OCCURRED. THE IFU STATES TO ¿WATCH PATIENT EXTREMITIES DURING TRANSFER ONTO THE TABLETOP¿, AND TO ¿MAKE SURE THAT PATIENT EXTREMITIES REMAIN ON THE TABLETOP DURING TRANSPORTATION AND DOCKING TO THE PATIENT SUPPORT.¿ THIS IS CONSIDERED AN UNFORTUNATE INCIDENT THAT COULD HAVE BEEN PREVENTED. THE USER HAS NOT STRICTLY FOLLOWED THE SAFETY INSTRUCTIONS AND WARNINGS TO PROTECT THE PATIENT. IN THIS CASE, THE PATIENT DID NOT FOLLOW STRICTLY INSTRUCTIONS FROM THE RADIOGRAPHER AND HAD NOT BEEN SUPPORTED WITH AN ARM SUPPORT OR STRAP (PROTECTIVE MEASURES TO PREVENT FINGER PINCHING) AT THE TIME OF THE ALLEGED HARM (WHICH, AS STATED IFU, SHOULD HAVE BEEN PROVIDED TO PREVENT THE PATIENT FROM GRABBING AROUND THE TABLE SIDES AND PINCHING THE FINGERS DURING VERTICAL TABLE MOTION, WHICH IS WHAT HAPPENED IN THIS EVENT). THE INSTRUCTIONS FOR USE CLEARLY MENTIONS THIS TYPE OF HAZARD AND HOW TO PREVENT IT FROM HAPPENING.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A REPORT THAT RADIOGRAPHER TRANSFERRED PATIENT TO FLEXTRAK WITH TABLETOP. PATIENT WAS ABLE TO MOVE HERSELF TO THE TROLLEY WITH TABLETOP. RADIOGRAPHER HELPED TO PLACE PATIENT¿S HAND ON HER CHEST AND INFORMED PATIENT TO KEEP HER HANDS ON HER CHEST. PATIENT NODDED IN RESPONSE TO THE INSTRUCTION GIVEN. RADIOGRAPHER COVERED THE PATIENT CHEST AREA WITH A BLANKET. RADIOGRAPHER PARKED FLEXTRAK TROLLEY TO PATIENT SUPPORT AND RAISED PATIENT SUPPORT VIA TUMBLE SWITCH. WHILE PATIENT SUPPORT WAS RAISING CLOSE TO ATTACH WITH TABLETOP, PATIENT INFORMED THAT SHE WAS IN PAIN AND RADIOGRAPHER STOPPED PATIENT SUPPORT MOTION IMMEDIATELY. RADIOGRAPHER CHECKED ON PATIENT STATUS AND FOUND HER LEFT HAND LOCATED IN BETWEEN THE PATIENT SUPPORT AND TABLETOP. RADIOGRAPHER LOWERED DOWN PATIENT SUPPORT TO RELEASE PATIENT'S HAND. RADIOGRAPHER NOTICED REDNESS ON PATIENT'S LEFT HAND AND ASKED THE PATIENT IF SHE WANTS TO PROCEED WITH THE SCAN OR CHECK ON HAND INJURY FIRST. PATIENT WANTED TO PROCEED WITH MRI SCAN. WARD NURSE AND MANAGER WERE INFORMED REGARDING THE INCIDENT. MEDICAL OFFICER ARRIVED TO CHECK ON THE PATIENT AFTER SCAN COMPLETED. PATIENT REQUESTED A HAND X-RAY. X-RAY OF LEFT HAND REPORTED AS AN UN-DISPLACED FRACTURE OF THE TUFT OF DISTAL PHALANX OF THE MIDDLE FINGER. THE MICROSURGEON SUGGESTED THE PATIENT NOT HAVE A CAST OR SPLINT SINCE SHE CAN FLEX AND EXTEND HER FINGER AND WAS PROVIDED WITH A MALLET SPLINT UPON DISCHARGE. THE REPORTED FINGER FRACTURE MEETS THE CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770327 INGENIA FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SMARTPATH TO DSTREAM FOR 3.0T 884838095083

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization| O