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

Model Number ORT300

Device Problem Break (1069)

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

Event Date 11/21/2018

Event Type  malfunction  

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 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
• 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: 13475757
• MDR Text Key: 286448592
• Report Number: 3010326005-2018-00041
• Device Sequence Number: 1
• Product Code: KXJ
• UDI-Device Identifier: 00857534006356
• UDI-Public: 00857534006356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: ORT300
• Device Catalogue Number: 114093-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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