MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722012

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed, a follow-up will sent to the fda.(b)(4).

Event Description

Philips received a complaint from the customer that the mavig support arm for the ceiling mounted radiation shield was broken.The device was in clinical use.There was no patient or user harm due to this issue.Philips has informed mavig.

Manufacturer Narrative

The field service engineer (fse) confirmed the broken support arm and replaced the arm with a new table mounted radiation shield this part has been send to the supplier (b)(4).(b)(4) tested this part and it meets the requirements.The weld does not show irregularities.The break results probably by overuse or a strong force impact.Conclusion of the analysis: the shield meets the requirements.The weld does not show irregularities.The break results probably by overuse or a strong force impact.Additionally, based on trending analysis there is no exceptional replacement rate for this item, therefore, we take no further action in this matter.(b)(4) tested this part and it meets the requirements.The weld does not show irregularities.The break results probably by overuse or a strong force impact.(b)(4).

• Brand Name: ALLURA XPER FD20
• 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: 5343520
• MDR Text Key: 35351509
• Report Number: 3003768277-2016-00002
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033737
• 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: 12/08/2015

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: 722012
• Device Catalogue Number: 722012
• Other Device ID Number: MAVIG SUPPORT ARM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2012
• 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