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

Model Number 722008

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When the investigation is completed, philips will inform the fda.

Event Description

Philips received a complaint from the customer in which they stated that the bracket that connects the suspension arm broke, therefore the suspension arm with the operating lamp fell on the wrist of the operator.No patient or user was harmed due to this issue.

Manufacturer Narrative

The field service engineer found that the metal bracket that connects the surgical light to the arm was broken and the lamp was unhooked when someone wanted to move it.The arm and metal bracket have been sent to philips best for investigation.Philips investigated the metal bracket together with their supplier (b)(4) and it became clear that the metal bracket that was used for connection between the arm and the lamp is not a part from (b)(4).Philips only works with (b)(4) brackets, so the part was not suitable for a secured connection.The installation and use of the surgical arms according to the instructions were investigated and considered sufficient.The field service engineer replaced the surgical light by the new examination led light (including the arm and bracket) and after replacement the device worked as intended.The newly installed surgical light has a suitable connection between the arm and the light.The light is less heavy and has a locking mechanism that prevents the light to be unhooked as happened with the previous light.(b)(4).

• Brand Name: ALLURA XPER FD20 BIPLANE
• 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: 5594177
• MDR Text Key: 44121062
• Report Number: 3003768277-2016-00041
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

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: 722008
• Device Catalogue Number: 722008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• 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