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

Model Number 712022

Device Problem Failure to Advance (2524)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Int ref: (b)(4).The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Event Description

The customer complained that the servo assisted tube movement suddenly stopped.One of the technicians was injured.No detailed information available at the moment.

Manufacturer Narrative

Int.Ref.: (b)(4).The digitaldiagnost is a radiographic system with ceiling suspended column and height adjustable table for general x-ray examinations.The movement of the ceiling suspended column is manual but with servo assistance.Philips field service engineer investigated on site.The customer stated that the ceiling suspended column auto assist was too strong, means the system was moving too easily.The field service engineer checked on the power assist strength and lowered the power setting.There was no system defect found.It has to be assumed that the technician let go off the all break release button unintended, when the system was on its way beyond the desired position, which resulted in a sudden stop (use error).The technician received pain in the shoulder.No intervention or medical treatment was necessary.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.The risk estimation revealed there was no unacceptable risk.The issue will be further monitored and trended.Correction: from consumer to health professional.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 DUAL DETECTOR
• 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: 8615585
• MDR Text Key: 145251854
• Report Number: 3003768251-2019-00009
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K090625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

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: 712022
• Device Catalogue Number: 712022
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1