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

Model Number 10018165

Device Problem Mechanical Problem (1384)

Patient Problems Laceration(s) (1946); Injury (2348); Joint Dislocation (2374)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

The mr system was checked by the local service engineer.All gaps were found to be within the specified range of <8mm.The root cause of the incident was determined as user error.The "magnetom espree, operator manual - mr system, syngo mr b19" *, page a.2-14 provides instruction to carefully monitor the patient during table movements.

Event Description

It was reported to siemens that a patient suffered an injury while undergoing an exam on the magnetom espree system.A female patient was positioned prone with feet facing the entrance to the mri tube.As the mr technologist raised the table the patient lowered her feet.She was wearing a sock and her third right toes became pinched in the gap between the table and the mri tube.The injury was described as an open dislocation and laceration of the toe.The patient required surgery with a pin placement in the toe.

• Brand Name: MAGNETOM ESPREE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; allee am roethelheimpark 2; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; allee am roethelheimpark 2; erlangen, 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6279077
• MDR Text Key: 65828102
• Report Number: 2240869-2017-64848
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/16/2017

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: Medical Technologist
• Device Model Number: 10018165
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR