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

Model Number 11060815

Device Problem Use of Device Problem (1670)

Patient Problems Hearing Impairment (1881); Patient Problem/Medical Problem (2688)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.(b)(6).

Event Description

It was reported to siemens that an adverse event occurred following servicing of the magnetom vida system.A siemens service engineer reported a loud noise while performing service on the mr system which resulted in tinnitus in both ears.The engineer was evaluated by a medical professional and treated with anti-inflammatory medication.The engineer continues to experience tinnitus and it is not clear whether the tinnitus is permanent at this time.Siemens is continuing to evaluate this reported incident.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined as a loose contact on a cable to the main switch.In the context of performing the update instruction mr003/18/p, the control unit (dgsu) is to be replaced.The system is to be switched off in order to perform this replacement.After performing the necessary work, the customer service engineer switched on fuse f21 and f1 as described in the update instructions.During the switching on, the engineer reported a loud noise which resulted in acoustic trauma on both ears.The engineer was treated with anti-inflammatory drugs for some weeks and according to the last medical report on (b)(6) 2019, the service engineer continues to suffer from ear problems.During the investigation, our experts concluded a loose contact of a cable to the main switch as the likely root cause for this event as there is no evidence to support an incorrect torque or fastening of the screws in production.To minimize the risk of a short circuit in the future, siemens will introduce a requirement for a "4 eyes" check of the screw fastening.Almost all gpas of all mr systems use this kind of connection of main switch and mains cabling.This is the first report of this type of error and therefore, considered a single event.At this time, the manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM VIDA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8482560
• MDR Text Key: 140904958
• Report Number: 3002808157-2019-63811
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K181433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 11060815
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 96