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

Model Number 722003

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that a service technician suffered an electrical body flow when replacing a single phase ups.According to the information received by philips, the dental prosthesis of the technician was broken.No serious injury has been reported.

Manufacturer Narrative

Philips investigated this complaint.The field service engineer got the shock when removing the contact plug (supply line to the host computer) from the switch box since the system was not fully switched off.The connection between the philips system and the ups is through a terminal block (x800).The ups installation instructions followed by the fse did not include a description of the terminal block (x800) and the indications on how to switch off the system were not detailed enough.Philips will update the installation instructions.No similar complaints were found.

• 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
• MDR Report Key: 7718845
• MDR Text Key: 115357328
• Report Number: 3003768277-2018-00053
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1