MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 722010

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Philips investigated this complaint.Philips checked the system on site and confirmed that the safety chain used to prevent the c-arm cover from falling was intact.The cover was re-attached and the system was returned to use in good working order.Since then, the issue has not reoccurred.Philips has opened an investigation as a follow up for the noted complaint.

Event Description

It has been reported to philips that the cover of the c-arm came loose.The cover was retained by a safety chain, which prevented the cover from falling off.The system was in clinical use but no harm was reported.

• Brand Name: ALLURA XPER FD10
• Type of Device: IMAGE INTENSIFIED 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: 9705984
• MDR Text Key: 191400532
• Report Number: 3003768277-2020-00010
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/27/2020

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2013
• 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