MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM FORCE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10742326

Device Problem Entrapment of Device (1212)

Patient Problem Limb Fracture (4518)

Event Date 11/24/2022

Event Type  Injury  

Event Description

It was reported to siemens that a hemiplegic patient with poor control was injured during an abdominal examination using the somatom force system.After completion of the abdomen scan the operator moved the patient table out of the gantry.During the movement of the patient table the patient´s left arm slipped into the gap between the gantry and the patient table and became trapped, resulting in a humeral fracture.The customer alleged that the patient table moved quickly, and the diameter of the table was too small, resulting in the operator having a blind spot.The user could not observe the upper limbs of the patient.The patient was not secured with an immobilization strap to affix the limbs and body the customer immediately sent the patient for additional diagnosis and the patient's arm was treated with plaster cast.The patient was in stable condition under the treatment.

Manufacturer Narrative

Siemens completed the technical investigation of the reported event.The logfiles of the event date were evaluated by the service engineer and revealed that no error occurred related to the patient table.The gap dimensions of the table were also investigated and showed that all gap dimensions are within specification.According to the information available, the patient's arms were placed at the sides of the body without the arms and body being secured with a restraining belt, as recommended per the system instructions for use.According to the instructions for use (print no.Hc-c2-058.621.07.02.02 - p.86) unintentional patient movement may cause injury to the patient: caution unintentional patient movement! injury to the patient.Always fix and observe the patient during the measurement.Caution unintentional patient movement! contusion of patient extremities at patient table and gantry.Always fix and observe the patient during system movements.Caution movable parts of the ct system! possible injury to the patient by moving parts.Always observe the possible contusion points shown in the following pictures.Based on the available information, no general product problem could be identified.This complaint will be closed without additional action.

• Brand Name: SOMATOM FORCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16034312
• MDR Text Key: 306014082
• Report Number: 3004977335-2022-54646
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female