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

Model Number 0072

Device Problems Unintended System Motion (1430); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

Please be informed that the reason for this report being late is that we first assessed this problem to be non-reportable.

Event Description

The overhead tube crane (otc) has spontaneously started a motorised movement downwards and continued until it collided with the table.No one was in the room.The user heard noise from the room and went back to find the otc standing against the tabletop.

• Brand Name: OMNERA 400A
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): ARCOMA AB; annavägen 1; växjö, 35246 ; SW 35246
• MDR Report Key: 12073571
• MDR Text Key: 261444380
• Report Number: 9616014-2021-00003
• Device Sequence Number: 1
• Product Code: KPR
• 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: Replace
• Type of Report: Initial
• Report Date: 06/22/2021

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: No Information
• Device Model Number: 0072
• Device Catalogue Number: 0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• 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