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

Model Number 722003

Device Problem Self-Activation or Keying (1557)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

A philips service engineer on site found a damaged cable bundle.During lateral table movement the cabling is cut into by the metal structure resulting in leakage current to earth.Apparently the system detects this and cuts power to the module.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 that while a patient was being treated in the cardiac catheter lab of the customer, the system itself activated the emergency stop without interference from the user.No patient harm was reported as a result of this issue, it is unknown what the outcome of the procedure was.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: it is assumed that because during lateral table movement the cabling is rubbing to the metal structure, eventually the cable is cut.When a cable is damaged, it will cause reduced functionality, which will be reported when detected, in which case the affected cable set will be replaced.Analysing the possible cable cuts and the effect on the patient of these different failures, shows that what can worst case happen is that motorized movement is not possible anymore, and the current procedure needs to be ended prematurely.Ending the procedure can still be done safely, as basic imaging functionality keeps working.

• 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: 5897845
• MDR Text Key: 53007641
• Report Number: 3003768277-2016-00077
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041949
• 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: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2008
• 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