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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Fall (1848); Bone Fracture(s) (1870); Concussion (2192)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

(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 informed us about a falling patient from a transfer board during x-ray examination.The transfer board was lying on a stretcher.Patient suffered two broken ribs, bruises and a concussion.Serious injury occurred.

Manufacturer Narrative

Int.Ref : (b)(4) the digitaldiagnost is a direct digital radiography system with wireless flat detector technology and is equipped with a ceiling suspended column (carrying the x-ray tube).The stretcher and transfer board are neither part nor accessories of the digitaldiagnost system.A patient with partly paralysis was to be examined.The planned x-ray examination was a hip examination, at which it is necessary to bend one knee in order to perform a x-ray shot on the hip.During the examination (operator had left the room for exposition) the patient lost balance in this position, the center of weight was moving to the side, the transfer board lying on the stretcher tipped over, and the patient fell to the floor.The investigation concluded that our system neither caused nor contributed the incident.No correction needed, the system works as specified.Conclusion 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: 8499647
• MDR Text Key: 141495141
• Report Number: 3003768251-2019-00006
• Device Sequence Number: 1
• Product Code: MQB
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/29/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization