MAUDE Adverse Event Report: PHILIPS HEALTHCARE BV ENDURA R2.3; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 718095

Device Problems Unintended Arm Motion (1033); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which it was stated that "when they released the brake of the c-arm, the c-arm dropped to the floor causing the arm to brake".The system was being prepared outside the room for use in a surgery procedure.The customer brought in another system to continue with the procedure.According a philips field service engineer the problem had no negative influence on the outcome of the procedure.

Manufacturer Narrative

Philips investigated this complaint.The system has been in use for almost 8 years.The c-arm did not detached completely from the system.When the brake was released, according to the customer the arm dropped to the floor causing the arm to brake.Per design the c-arm is held at multiple points.Based on the analysis of the pictures of the broken part, it is considered that the issue was caused by handling of the system.The system is parked at the 4th floor of the hospital and moved to the ground floor for procedures.Pushing in and out of the lifts and the lifts having a gap and not lining up may have caused extra strain on the horizontal movement assembly welding.The horizontal assembly was replaced at the customer site.Search in the trackwise complaints database has not shown similar complaints.No further actions will be taken by philips as no structural issue has been identified.

• Brand Name: BV ENDURA R2.3
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 6935358
• MDR Text Key: 90068687
• Report Number: 3003768277-2017-00085
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K010435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 718095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Date Device Manufactured: 02/14/2011
• 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