MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722003

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

According the philips field service engineer the inserts on x-ray tube housing have come loose.When the investigation has been completed philips will inform the fda.

Event Description

Philips was informed that during a procedure the user noticed that the x-ray tube came loose.The user was able to finish the procedure by placing the tube back in place.No patient or user harm was reported due to this issue.

Manufacturer Narrative

Philips investigated this complaint.The tube was replaced and the system is back in working order.Analysis of the replaced tube showed that the tube inserts were pulled out of the housing.Based on the investigation performed, two factors might have contributed to this problem: the installation of the x-ray tube that was performed without using the installation manual and specifically the instructions that require the use of a torque wrench to determine that the bolts of the tube are tightened with 20n.The replaced tube was a refurbished tube and its verification did not follow an additional instruction for testing of the tube inserts.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 7230342
• MDR Text Key: 98787628
• Report Number: 3003768277-2018-00006
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• 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: 01/11/2018

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: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2005
• 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