MAUDE Adverse Event Report: PHILIPS HLTHCARE ALLURA XPER FD10/10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722011

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A field service engineer went on site to solve an issue with the shutter that was visible on lateral x-ray images.During the svc activity, x-ray tube fell off from l-arc, 6 nut sleeves came apart from x-ray tube housing.In this case no pt or user was harmed.

Manufacturer Narrative

(b)(4).When investigation is completed, a f/u report will be sent to fda.

Manufacturer Narrative

Investigation of this event lead to the conclusion that the issue was caused by the fact that the inserts being mounted manually in the tube mounting plate can be damaged during the mounting of the tube to the system.The probability of any harm during clinical use is very unlikely.This issue is considered and handled as an isolated incident.

Event Description

Field service engineer went on site to solve an issue with the shutter that was visible on lateral x-ray images.During the service activity, x-ray tube fell off from l-arc, 6 nut sleeves came apart from xray tube housing.In this case no patient or user was harmed.

• Brand Name: ALLURA XPER FD10/10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HLTHCARE; veenpluis 4-6; best 5680D A; NL 5680DA
• Manufacturer Contact: deborah thurston ; 3000 minuteman rd; andover, MA 01810 ; 9786592010
• MDR Report Key: 4524258
• MDR Text Key: 5495187
• Report Number: 3003768277-2015-00013
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2015

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: 722011
• Device Catalogue Number: 722011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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