MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - MR MAGNETOM VIDA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	11060815
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens initiated an investigation of the reported incident.A supplemental report will be submitted if additional information is received upon conclusion of the investigation.
Event or Problem Description
It was reported that the patient's hand was injured after an examination using the magnetom vida system.Wooden steps were located on the right side of the patient table (patab).The patient put his right hand on the edge of the patab when the table was being lowered and the patient's fingers were caught between the edge of the patient table and the wooden steps.Patient's right hand middle finger was fractured and both middle finger and fourth finger suffered soft tissue injury.The injuries were treated with 20 sutures in total, the avulsed skin was regrafted, and the hand was immobilized.
Additional Manufacturer Narrative
H10 manufacturer narrative: siemens completed the investigation of the reported event.As previously reported, siemens was informed that the patient's hand was injured after an examination using the magnetom vida system.Wooden steps were located on the right side of the patient table (patab).The patient put his right hand on the edge of the patab when the table was being lowered and the patient's fingers were caught (pinched) between the edge of the patient table and the wooden steps.Patient's right hand middle finger was fractured and both middle finger and fourth finger suffered soft tissue injury.The injuries were treated with 20 sutures in total, the avulsed skin was regrafted, and the hand was immobilized.The mr system was checked and found to be in specification.Siemens assessed the complained event and concluded that the cause of this event was a user error.The stairs are not siemens healthineers equipment, and these stairs are the root cause for the patient's injury.This issue was not caused by a technical deviation of the mr system but by inattentiveness of the operator.It is in the responsibility of the operator to take care that the patient is safely laying on the table during table movements.The magnetom vida operator manual - mr system; syngo mr xa 10 (page 28) provides clear instructions to carefully monitor the patient during table movement.This complaint was closed.H11 corrected data: d3: device was not serviced by a third party.This field should have been checked "no" in the initial report submitted to the fda on december 15.2022.

• Brand Name: MAGNETOM VIDA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15993096
• Report Number: 3002808157-2022-54576
• Device Sequence Number: 6151074
• Product Code: LNH
• UDI-Device Identifier: 04056869039176
• UDI-Public: 04056869039176
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K220425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: 11060815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown