MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722012

Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

Patient Problem No Code Available (3191)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Philips has been reported that during a stroke procedure when the patient was already anesthetized and intubated, and a femoral cannulation performed to insert the catheter to the brain, the patient bed of the system stopped and the message ¿georeset¿ was shown.Several attempts were made to shut down/restart the system with no positive results, during which the patient bed remained locked even when it was not being powered.Then the system turned off.The patient was transferred to another area and floor of the hospital.The attempts to recover and the transfer contributed to a total delay of around 40 minutes in the diagnosis/interventional procedure.A the time of this report, philips does not have information on the status of the patient.The event has been reported by the customer to the italian ministry of health as an incident (i.E.Serious deterioration in health).Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated this complaint.Philips identified that the f4 circuit breaker in the mains power distribution unit (mpdu) had tripped.This circuit breaker powers the cabinet that is dedicated to the geometry.When a circuit breaker trips, the geometry does not receive any power.The f4 circuit breaker is a safety device that trips, for example, when excessively high current passes through it, like a fuse.The tripping is part of the safety measures to avoid severe damage to equipment and potentially hazardous situations caused by a short circuit downstream.Furthermore, philips identified that the battery of the universal power supply (ups), which provides back-up power to downstream components, was defective.Philips service engineer replaced the defective ups and returned the system to use in good working condition.Philips has not been able to determine the cause of the f4 circuit breaker trip.There is no significant trend in similar incidents.Philips has completed a good faith effort to gather further information regarding the patient and procedure.However, the customer has not provided any additional information due to patient privacy.Consequently, philips has closed this complaint.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8657727
• MDR Text Key: 146621980
• Report Number: 3003768277-2019-00043
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 74 YR