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

Model Number 722010

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 08/09/2016

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 that during a procedure the equipment turned off four times, each time with an interval of around one minute.At the fifth time the equipment was reinitiated and the medical study was finished but the patient had a ventricular fibrillation caused by the waiting time with the intra cardiac catheter inside the patient without the possibility of visualization.The client alleges that the patient had a ventricular fibrillation caused by the waiting time with the intracardiac catheter without the possibility of visualization.Patient was defibrillated with success.

Manufacturer Narrative

Philips investigated the complaint and came to the following conclusion: the philips field service engineer (fse) troubleshot this issue and stated that this was due to an electrical problem in the hospital.It was found that the voltage guard was working with a limited voltage range of 415v - 380v, so having a voltage outside of this range would activate it and turn off the equipment for lack of power.So due to variations on the voltage of the electrical supply, it turned off the system several times, what made the operating personnel restart the system on the electrical board of the hospital.The failure is due to an external cause, namely the hospital power supply.The inhouse electrician could change the voltage range from 415v to 420v, but the philips igt does not recommend an automatic voltage regulator (avr) due to the pulsed load behavior of the allura device.The failure is due to an external cause, namely the hospital power supply, the hospital is considering an uninterruptible power supply (ups) to prevent those issues in the future.

• 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: 5871275
• MDR Text Key: 51933487
• Report Number: 3003768277-2016-00076
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2013
• 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): Life Threatening
• Patient Age: 73 YR