MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 HIGH PERFORMANCE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712031

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is still ongoing for this event.When the investigation is completed a follow-up will sent to the fda.

Event Description

The customer complained that the operator received an shock by touching the computer on the backside.No medical treatment necessary.

Manufacturer Narrative

Int ref.: (b)(4).The digitaldiagnost is a direct digital radiography system with flat detector technology based on modular components.This digitaldiagnost system is connected via a back box (wall junction box) to the hospital electrical raceway system.This back box (intended to be used in the united states and canada only) is not a part of the medical electrical system but is part of the pre installed hospital building infrastructure and its installation and is expected to be completed before the system installation starts.Philips shares with customers the pre installation requirements beforehand.The philips healthcare field service engineer has investigated on site.He identified that the wiring from the house power supply to the back box was not correct.The ground wire (protection earth) from the hospital mains was connected to the neutral connector in the back box instead of the ground connector.Philips field service engineer connected the ground wire to the ground connection of back box.Device is now within manufacturers¿ specification.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for reporting.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.Correction: h6: result and conclusion code 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: DIGITALDIAGNOST 4.1 HIGH PERFORMANCE
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 8780113
• MDR Text Key: 150817221
• Report Number: 3003768251-2019-00010
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 00884838065321
• UDI-Public: (01)00884838065321
• Combination Product (y/n): N
• PMA/PMN Number: K141736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

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: 712031
• Device Catalogue Number: 712031
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1