MAUDE Adverse Event Report: ARCOMA AB OMNERA 400T; STATIONARY X-RAY SYSTEM

Model Number 0180

Device Problem Misassembled During Installation (4049)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Please be informed that the reason for this report being late is that i have encountered problems regarding enrollment of the emdr program.The report was completed on april 20, 2021 but i could not submit it.

Event Description

A mechanical bracket for overhead tube detent (40" mark) fell from the ceiling rail during an examination.

• Brand Name: OMNERA 400T
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): ARCOMA AB; annavägen 1; växjö, 35246 ; SW 35246
• MDR Report Key: 12073574
• MDR Text Key: 261445055
• Report Number: 9616014-2021-00001
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 1200117212119
• UDI-Public: 0107350008750050011200117212119
• Combination Product (y/n): N
• PMA/PMN Number: K140683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0180
• Device Catalogue Number: 0180
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1