MAUDE Adverse Event Report: ARCOMA AB RADPRO OMNERA 400A; 0180 INTUITION AND 0072 PRECISION STATIONARY DIGITAL X-RAY SYSTEMS

Model Number 0072

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

Unstable results at aec exposures have been noted during clinical use in a children's hospital.During troubleshooting, a component failure in a transformer in the x-ray generator has been detected and corrected.After the generator has been repaired, the generator operates as intended.No further action is needed in since this is a single event.No reports of similar events have been reported.The system has an inbuilt exposure index display feature that allows the user to detect any discrepancies after each exposure.This feature has functioned as intended, component failures or other types of incorrect settings could quickly be detected and actions taken.This report is not meeting the fda's required reporting time frames due to the fact that arcoma did not identify this incident as a reportable event.However, after careful study of the event and considering that the patients are children (children hospital) arcoma decided to send this report to fda.

Event Description

Unstable aec-exposures have been noted during clinical use at a children hospital.The average exposure index has been 3.5 times larger than for similar systems.

• Brand Name: RADPRO OMNERA 400A
• Type of Device: 0180 INTUITION AND 0072 PRECISION STATIONARY DIGITAL X-RAY SYSTEMS
• Manufacturer (Section D): ARCOMA AB; annavägen 1; växjö, 35246 ; SW 35246
• Manufacturer (Section G): ARCOMA AB; annavägen 1; växjö 35246
• Manufacturer Contact: elisabeth lundahl ; annavägen 1; växjö, 35246 ; SW 35246
• MDR Report Key: 7330554
• MDR Text Key: 102096733
• Report Number: 9616014-2018-00002
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 07350008750012
• UDI-Public: 07350008750012
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K140683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2014
• 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