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

Model Number 722001

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

Patient Problems Bruise/Contusion (1754); Injury (2348)

Event Date 06/01/2015

Event Type  Injury  

Event Description

The customer reported that during preparation of an exam the exam light fell down from the ceiling support, a nurse was hit on the elbow by the exam light.This caused a bruise on the elbow of the nurse.

Manufacturer Narrative

When investigation is completed a follow up report will be sent to fda.(b)(4).

Manufacturer Narrative

Philips has investigated the complaint and came to the conclusion that the problem was related to a product that is not manufactured by philips.The manufacturers of the mavig arm and mach lamp were informed by philips (b)(4).Philips will not do any further investigation.(b)(4).

Manufacturer Narrative

The philips (b)(4) customer support department has investigated the issue together with the arm supplier ((b)(4)) and concluded that the issue was caused by a mistake made during installation.The installation instructions were not followed which resulted in two screws being mixed up, which led to an improper screw (too short) being installed to attach the mach lamp.An installation guide was available on site, but was not properly followed by the philips (b)(4) field service engineer.Following the installation guide would have prevented the issue from occurring.We learned that the lamp assembly without arm was replaced which solved the issue.The system was returned to the customer in working order.The problem is related to a product that is not supplied and/or maintained by (b)(4) in best the (b)(4).The manufacturers of the (b)(4) arm and mach lamp were informed by philips (b)(4).

• Brand Name: ALLURA XPER FD10 C
• 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 Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 4931969
• MDR Text Key: 6033427
• Report Number: 3003768277-2015-00059
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: 722001
• Device Catalogue Number: 722001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/30/2015; 12/17/2015; 12/24/2015
• 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
• Patient Outcome(s): Other