MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 OR TABLE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722015

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda.(b)(4).

Event Description

Philips received a complaint from the customer in which they stated that support connector on ceiling has snapped off.No injuries were reported.

Manufacturer Narrative

When the system is parked, the upper part of the l-arc was able to touch the cable hose and over time this caused it to slide the cable hose through the hanger.When the cable hose got to a point of being short enough, this caused too much stress on the hanger bolt and it snapped, allowing the cable hose to drop to a height where a person could collide with it.The field service engineer concluded that the cable hose from the stand had moved through the hanger because of careless use by the customer.He replaced the bolt and remounted the cable hose hanger back on the ceiling carriage.The system was returned to the customer in working order.(b)(4).

• Brand Name: ALLURA XPER FD20 OR TABLE
• 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: 5584350
• MDR Text Key: 43767661
• Report Number: 3003768277-2016-00039
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130842
• 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: 03/20/2016

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: 722015
• Device Catalogue Number: 722015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• 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