MAUDE Adverse Event Report: PHILIPS HEALTHCARE CESAR/C-STANDFLOOR-OMCP-VISUB-CCD(V5000); ANGIOGRAPHIC X-RAY SYSTEM

Model Number 72248

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Type  malfunction  

Event Description

Philips received a complaint from the customer in which it was stated that a lead shield (for x-ray protection) attached to the ball socket at the bottom of the arm came apart and fell on the ground.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: a philips field service engineer (fse) confirmed this issue and replaced the ceiling mounted radiation shield supplied directly by mavig.The shield was 16 years old and the malfunction was due to corrosion according to the fse.The shield attached to the ball socket at the bottom of the arm came apart.This was due to the top of the arm not rotating.The lead glass fell on the ground with him holding it.The radiation shields are not manufactured by philips.Philips informed the manufacturer of the radiation shields about this event.

• Brand Name: CESAR/C-STANDFLOOR-OMCP-VISUB-CCD(V5000)
• Type of Device: ANGIOGRAPHIC 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: 6342925
• MDR Text Key: 68091771
• Report Number: 3003768277-2017-00018
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

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: 72248
• Device Catalogue Number: 72248
• Other Device ID Number: MAVIG LEAD SHIELD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2000
• 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