BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM GO.ALL

    MDR report key: 14140473 · Received April 19, 2022

    Report

    Report Number
    3004977335-2022-22784
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 19, 2022
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAK
    UDI-DI
    04056869151564
    PMA / PMN Number
    K211373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ALTHOUGH IT REPORTED THAT THE PATIENT WAS "RESTRAINED" DURING THE EXAMINATION, THE PATIENT WAS ABLE TO BREAK THE PLEXI-RING WITH HIS KNEE, SUSTAINING A MINOR ABRASION. PROPER FIXATION OF THE PATIENT BEFORE THE PROCEDURE IS RECOMMENDED IN THE SYSTEM USER MANUAL. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME. THE PLEXI-RING WILL BE REPAIRED.

    Additional Manufacturer Narrative · 0

    H10: THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ALTHOUGH IT REPORTED THAT THE PATIENT WAS "RESTRAINED" DURING THE EXAMINATION, THE PATIENT WAS ABLE TO BREAK THE PLEXI-RING WITH HIS KNEE, RESULTING IN A HIP FRACTURE AND A MINOR ABRASION. PROPER FIXATION OF THE PATIENT BEFORE THE PROCEDURE IS RECOMMENDED IN THE SYSTEM USER MANUAL. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME. THE PLEXI-RING WILL BE REPAIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AFTER THE TOPOGRAM (LOW DOSE OVERVIEW SCAN) AND DURING THE SPIRAL ACQUISITION (VOLUME SCAN), THE PATIENT BROKE THOUGH THE CT GANTRY PLEXI-RING WITH HIS KNEE. THE PATIENT SUSTAINED A MINOR INJURY TO HIS KNEE (SKIN ABRASION) DURING THE EVENT BUT REPORTEDLY, NO MEDICAL INTERVENTION WAS NEEDED. THE FACILITY REPORTED THAT THE PATIENT HAD BEEN "RESTRAINED" ON THE CT TABLE WHEN THE EVENT OCCURRED. THE PATIENT HAD BEEN TRANSFERRED FROM AN ELDER CARE FACILITY THROUGH THE FACILITY EMERGENCY ROOM (ER) DUE TO A BROKEN HIP. THE REPORTED EVENT OCCURRED DURING THE CT EXAMINATION OF THE HIP. AFTER THE SCAN EVENT, THE PATIENT'S BROKEN HIP WAS TREATED AT THE FACILITY ER AND WAS RETURNED TO THE LONG-TERM CARE FACILITY WHERE HE CAME FROM. THE PATIENT WAS NOT AMBULATORY. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER ON APRIL 19, 2022. STATING THAT THE PATIENT'S HIP FRACTURE WAS SUSTAINED DURING THE REPORTED EVENT. UPDATED EVENT DESCRIPTION: IT WAS REPORTED TO SIEMENS THAT AFTER THE TOPOGRAM (LOW DOSE OVERVIEW SCAN) AND DURING THE SPIRAL ACQUISITION (VOLUME SCAN), THE PATIENT BROKE THOUGH THE CT GANTRY PLEXI-RING WITH HIS KNEE. THE PATIENT SUSTAINED A HIP FRACTURE DURING THE EVENT AND A MINOR INJURY TO HIS KNEE (SKIN ABRASION). THE FACILITY REPORTED THAT THE PATIENT HAD BEEN "RESTRAINED" ON THE CT TABLE WHEN THE EVENT OCCURRED. THE REASON FOR THE CT INITIAL CT SCAN IS UNKNOWN. THE PATIENT HAD BEEN TRANSFERRED FROM AN ELDER CARE FACILITY FOR THE INITIAL SCAN AND AFTER THE EVENT, WAS TRANSFERRED TO THE FACILITY EMERGENCY ROOM FOR TREATMENT OF THE HIP FRACTURE. THE PATIENT WAS LATER RELEASED BACK TO THE ELDER CARE FACILITY AND IS NOT AMBULATORY. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627547 SOMATOM GO.ALL SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH 11061630 04056869151564

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention| O