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

Model Number	10684332
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Laceration(s) (1946); Joint Dislocation (2374)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was injured during movement into the gantry after the patient positioning procedure.Additional information received by siemens on december 13, 2022, clarified that the patient's fifth digit on the right hand became stuck between tabletop and body coil.According to the hospital staff, soft tissue swelling of the digit was observed at the time of incident.Furthermore, it was stated that there was a laceration which required three (3) sutures and the digit was dislocated.The patient required a surgical procedure to resolved severe ulnar deviation of the metacarpophalangeal joint of the fifth digit.
Additional Manufacturer Narrative
Siemens initiated a detailed investigation of the reported incident.A preliminary investigation of the reported event was performed.Siemens observed that hazard warning tables signs on both side of the magnet cover were present.Siemens measured the clearance between table and magnet cover and found it to be within 3-8mm.The left right gap between patient table and magnet cover were not even.Siemens checked and realigned the left and right sides of the patient table.A comprehensive inspection has been performed on the patient tabletop and magnet cover to obtain best gap without interfering with the operation of the tabletop movement.A supplemental report will be submitted if additional information is received upon conclusion of the investigation.
Additional Manufacturer Narrative
H10 manufacturer narrative: siemens completed the investigation of the reported event.As previously reported, siemens was informed that the patient was injured during movement into the gantry after the patient positioning procedure.Additional information received by siemens on december 13, 2022, clarified that the patient's fifth digit on the right hand became stuck between tabletop and body coil.According to the hospital staff, soft tissue swelling of the digit was observed at the time of incident.Furthermore, it was stated that there was a laceration which required three (3) sutures and the digit was dislocated.The patient required a surgical procedure to resolved severe ulnar deviation of the metacarpophalangeal joint of the fifth digit.According to the siemens service technician, the gap on the right side between body coil and tabletop was 10mm instead of the required maximum of 8mm.The gap measurement of 10mm contributed to the patient's finger becoming stuck in the gap.Furthermore, 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 avanto operator manual - mr system; syngo mr d13, page a.2-14, provides clear instructions to carefully monitor the patient during table movement.Siemens recommended that the operation staff be retrained.The siemens service engineer visited the customer site to adjust the tabletop distances so they will be within specification.The system is now within specification.The complaint was closed.

• Brand Name: MAGNETOM AVANTO DOT UPGRADE
• 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: 15988001
• Report Number: 3002808157-2022-56429
• Device Sequence Number: 20243029
• Product Code: LNH
• UDI-Device Identifier: 04056869006635
• UDI-Public: 04056869006635
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K121434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10684332
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 03/09/2023
• 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 Age: 65 YR
• Patient Sex: Female