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

Model Number 722026

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 06/21/2017

Event Type  Death  

Manufacturer Narrative

Analysis of the logfile shows that they chose via the touchscreen a ¿2d rotation¿ program at 10:33.This program was active until they did the restart of the system about 30 minutes later.By using this program, you have to confirm and end- and start position before you can make a rotation run (exposure).The table top is fixed end exposures are not possible until you end this procedure or just choose an other program like ¿coronary¿ for example.When the investigation has been completed, philips will inform the fda.

Event Description

Philips received a complaint in which it was stated that: at about 10:33, the tabletop was fixed and could not do exposure runs.They had the message ¿confirm rotation scan start position¿ on the monitor.Some minutes later, they pressed the geo-stop-button and had due to this action a floating table top and did not know what to do.Not until after about 30 minutes, they made a system restart and the system was working fine again.Between this actions they had to reanimate the patient.Some minutes later, there was the short circuit at the injector due to urine from the patient during reanimation.Eventually the patient died.

Manufacturer Narrative

Philips analyzed the log file of the system and confirmed that during the procedure the customer chose a ¿2d rotation¿ program.When using this program the customer has to confirm the start-end-position before they can make a rotation run ((the message ¿confirm rotation scan start position¿ will be shown on the monitor).The tabletop is fixed and exposure is not possible until the customer ends this procedure or chooses another program.The geo-stop button was then pressed and as a result the table becomes floating.After 30 minutes the system was restarted and operated without problems till there was a short circuit in the acist cvi-injector (not manufactured by philips).The ¿2d rotation¿ program remained active until they performed the restart of the system later.Philips replaced the pdm1 power supply and fuses of the allura system and the system was operational again.During the investigation it was confirmed that the power supply of the acist cvi-injector is usually mounted at the foot end of the tabletop.During this procedure though it was placed under the tabletop with the electrical connections and ¿on/off switch¿ on top.The injector was not switched off.The customer confirmed that the acist cvi-injector was not used for this procedure.The short circuit in the power supply of the acist cvi-injector was due to liquid (urine) entering the injector.The power supply of the acist cvi-injector is powered via the ad7 table from the pdm1 power supply of the geometry cabinet.The short circuit of the acist cvi-lnjector caused the interruption of two fuses, the fuse protecting the output powering the acist cvi-injector and the fuse of the electronic switch powering a group of outputs.The geo pc and geo id box (table and mcs) are also connected to this group of outlets, which in turn lead to the situation that the geometry could not be used anymore.When the geometry is not available, the imaging functionality is still available to end a procedure in a controlled manner.The fuses acted as intended to prevent dangerously high current entering into the allura system.No system malfunction has been confirmed.No further actions will be taken by philips.

• 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: 6673089
• MDR Text Key: 78585565
• Report Number: 3003768277-2017-00063
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031333
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722026
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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): Death