MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS ORT300 OPERATING ROOM TABLE; OPERATING ROOM TABLE,

Model Number	ORT300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer service engineer replaced the two actuators and cycled them to verify proper operation.Furthermore, the broken pin in the rotational locking mechanism was replaced.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 or Problem Description
On (b)(6) 2018, a customer service engineer (cse) repaired the floor latch of an ort300 table.In addition, the cse inspected the rotational lock mechanism of the table and discovered a broken pin.The broken pin did not allow the table to lock in the rotational function.There was no patient involvement.

• Brand Name: IMRIS ORT300 OPERATING ROOM TABLE
• Common Device Name: 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: 13475757
• Report Number: 3010326005-2018-00041
• Device Sequence Number: 5233270
• Product Code: KXJ
• UDI-Device Identifier: 00857534006356
• UDI-Public: 00857534006356
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ORT300
• Device Catalogue Number: 114093-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2014
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown