MAUDE Adverse Event Report: KONICA MINOLTA HEALTHCARE AMERICAS KDR AU 4000 U-ARM; SYSTEM, X-RAY, STATIONARY

Model Number	KDR AU-4000
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary attached: no.The device was evaluated and tested but investigation is still active.Results are pending completion of all aspects of investigation to be evaluated.(b)(4).
Event or Problem Description
It was reported by the engineer that our customer contacted them stating that during a hip lateral exposure the stand started moving and lifting up the table with the patient on it.There were three technicians observing the procedure.Technician #1 ran into the room and was able to move the table with the patient on it out of the way.Technician #2 pressed buttons on the tablet enclosure and the stand stopped moving.A technician stated that during the alleged malfunction, the remote was laying on the counter and that the only person in the room was the patient.Technician #3 was there and observed it all occur.A field service engineer (fse) was dispatched to assist cms imaging engineer troubleshoot by phone.

• Brand Name: KDR AU 4000 U-ARM
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): KONICA MINOLTA HEALTHCARE AMERICAS; 2217 us highway 70 e; garner NC 27529
• MDR Report Key: 7976027
• Report Number: 1064396-2018-00000
• Device Sequence Number: 16488973
• Product Code: KPR
• UDI-Device Identifier: 00817100020056
• UDI-Public: 00817100020056
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K082604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/11/2018

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
• Operator of Device: Health Professional
• Device Model Number: KDR AU-4000
• Device Catalogue Number: KIT-KDR-AU-4000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1