MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS NEURO III-SV SYSTEM WITH SIEMENS DIAGNOSTIC TABLE; OPERATING ROOM TABLE

Model Number NEURO III-SV

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

The siemens diagnostic tim table is part of the imris neuro iii-sv system at florida hospital.The cause of the incident was traced to mri technologist user error.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.

Event Description

On (b)(6)2019, the customer reported that the patient was on the siemens diagnostic table and the table dropped approximately 3mm in position.There was no harm or user injury reported due to the event.

• Brand Name: IMRIS NEURO III-SV SYSTEM WITH SIEMENS DIAGNOSTIC TABLE
• Type of Device: OPERATING ROOM TABLE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): IMRIS - DEERFIELD IMAGING, INC; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13441689
• MDR Text Key: 295982296
• Report Number: 3010326005-2019-00043
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEURO III-SV
• Device Catalogue Number: 105117-004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2011
• 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