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

Model Number KDR AU-4000

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)

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

Event Date 09/13/2018

Event Type  malfunction  

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 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
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): KONICA MINOLTA HEALTHCARE AMERICAS; 2217 us highway 70 e; garner NC 27529
• Manufacturer (Section G): KONICA MINOLTA HEALTHCARE AMERICAS; 2217 us highway 70 east; garner NC 27529
• Manufacturer Contact: jan maniscalco ; 2217 us highway 70 east; garner, NC 27529 ; 8009341034
• MDR Report Key: 7976027
• MDR Text Key: 126092854
• Report Number: 1064396-2018-00000
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 00817100020056
• UDI-Public: 00817100020056
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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