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

Model Number 722028

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Installation-Related Problem (2965)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

Flexvision 58" monitor is mounted on the third party boom.Philips 220v was wired to wrong block.No sign that unit has two power sources.Third party engineer was working on ts boom because it would not move up or down.The third party engineer thought power was secure but philips 220v was on wrong terminal block and he was not aware that it was power from two sources.When the investigation has been completed philips will inform the fda.

Event Description

Philips received a complaint from the customer in which was stated that a third party service engineer received a shock while servicing the third party monitor boom.The third party service engineer received a 220 volt shock because the power supply of the philips flexvision monitor was incorrectly installed on this third party monitor boom.The third party service engineer did not need any treatment after the shock and could continue working.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: a philips field service engineer (fse) installed the 110v for the philips monitor to the steris powerblock.The steris fse thought that the power was off and got a small shock since the power was not off on the philips device.The steris fse reconnected the wires from the steris powerblock and connected the steris equipment correctly.The philips fse connected the 110v to the philips powerblock and tested the assembly.It worked as intended.The steris engineer should have checked if the appliance is de energized, this is the procedure in steris installation manual.In the customer complaint database (2014-2017) there are no complaints regarding steris boom parts known.Also fse workmanship complaints regarding wrong powerblock connections are not known.We can conclude this incident is a onetime occurrence.

• 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
• 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: 6292241
• MDR Text Key: 66495367
• Report Number: 3003768277-2017-00009
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141979
• 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: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722028
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• 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