MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILLIPS C-ARM ALLURA XPER FD 10

Model Number 9896-002-00542

Device Problems Repair (1529); Other (for use when an appropriate device code cannot be identified) (2203); Device Operates Differently Than Expected (2913)

Patient Problem Discharge (2225)

Event Date 06/30/2017

Event Type  malfunction  

Event Description

This is being turned in as a patient safety concern.Risk received a call from the cath lab that they were in the middle of performing an angiogram and the c-arm turned 180 degrees around.One was injured but this is a safety issue.The unit had pm services performed the night before and had no issues.The c-arm was taken out of service and checked by our biomed and their contract company found that the c-arm propeller drove all the way past its end stop.Found the encoder was bad causing this to occur.The part was replaced, tested and no duplication of problem occurred.C-arm put back in service.This is one of our newer units and our biomed department stated they had never seen this occur before.Patient was discharged home.

• Brand Name: PHILLIPS C-ARM ALLURA XPER FD 10
• Type of Device: C-ARM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett highway; po box 3003; bothell WA 98041 3003
• MDR Report Key: 6731240
• MDR Text Key: 80752656
• Report Number: 6731240
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2017

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
• Device Operator: Health Professional
• Device Model Number: 9896-002-00542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2017
• Distributor Facility Aware Date: 06/30/2017
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR