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

Model Number	0072
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 0180 INTUITION AND 0072 PRECISION STATIONARY DIGITAL X-RAY SYSTEMS
• Manufacturer (Section D): ARCOMA AB; annavägen 1; växjö, 35246 ; SW 35246
• MDR Report Key: 7330554
• Report Number: 9616014-2018-00002
• Device Sequence Number: 144592
• Product Code: KPR
• UDI-Device Identifier: 07350008750012
• UDI-Public: 07350008750012
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/12/2017

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: No Information
• Device Model Number: 0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1