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

Model Number 722003

Device Problem Failure to Power Up (1476)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 02/18/2017

Event Type  Injury  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which it was stated that: the patient was brought to the cath lab emergently from the er for a code crimson (stemi).Physician stepped on fluoroscopy pedal and the fluoroscopy did not turn on.The team rebooted the equipment which did not correct the problem.Patient became unstable developed ventricular tachycardia (vt) / ventricular fibrillation (vf)and was shocked several times.Patient was transferred to cath lab 1.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: a philips system designer and a philips generator engineer concluded that the error was caused by opened spring contacts of the safety resistors.Both specialists were unable to identify the cause for the opened spring contacts.No parts of the generator were found to be defective, only the spring contacts of the safety resistors were opened.The resistors are needed to limit the inrush current to the velara generator (charge of the capacitors in the intermediate voltage circuit of the converters) and to prevent for a overcurrent damage of the generator.When the safety resistors are tripped, x-ray generation is no longer possible.This issue was most likely caused by an external factor and not by a malfunction of the system.They suspect an asymmetry in the mains to be the cause of the blown safety resistors.The system was in an active state for a long time (no standby request was sent to the system interface).When the generator stays for a long time in an active state, and there is an asymmetry in the mains value, it is possible that the spring contacts of the safety resistors can blow.Philips is unable to determine if the delay in procedure due to the malfunction of the system, contributed to the decrease in ejection fraction for the patient.The outcome of the initial risk assessment showed that the risk of harm for this issue is within acceptable limits.Trend data for this failure mode shows a stable failure rate in the last 5 years.This delay of treatment is within all risk limits.The field service engineer replaced the safety resistors, which solved the issue.

• 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: 6406410
• MDR Text Key: 70005107
• Report Number: 3003768277-2017-00031
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2017

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: 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
• Initial Date Manufacturer Received: 02/18/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: 02/18/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2007
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 85