MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MRI SCANNER

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2016

Event Type  malfunction  

Event Description

Patient arrived from o.R.Sedated with probe in place.Mri scanner did not work.Rebooted several times.Moved patient to 3t scanner.The 3t scanner also would not work.Siemens service called.Attempted to assist over the phone.Unable to fix scanner.Engineer arrived.Noticed (b)(4) vendor for (b)(4) computer had loosened the scanner network cables while hooking up their cable.This delay was 3 hours.Patient was under anesthesia and on the mri table the entire time.Engineer was able to get scanner back on line.

• Brand Name: MRI SCANNER
• Type of Device: MRI SCANNER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 6221395
• MDR Text Key: 63834796
• Report Number: 6221395
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2016,12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: CLINICAL ENGINEERING # 44029
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR