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

Model Number 722026

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.(b)(4).

Event Description

Philips received a complaint from the customer in which they stated a user experienced an injury during cleaning of the arm of the lead shield protection.A metal spring was sticking out of the cover this caused a cut in the arm of the user (around 3-4cm).The medical staff treated the user with 5 stitches.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: this incident occurred due to incorrect installation of the safety spring on the mavig arm.The spring was inserted short end first instead of long end first, as described in the manual, therefore a part of the spring was sticking out of the cover.A philips service engineer re- installed the safety spring correctly according the manual.There are no reports known at philips that more arms are installed incorrect.(b)(4).

• 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: 5856143
• MDR Text Key: 51453170
• Report Number: 3003768277-2016-00074
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031333
• 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: 08/01/2016

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 Model Number: 722026
• Device Catalogue Number: 722026
• Other Device ID Number: MAVIG OT80001 ARM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• 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