MAUDE Adverse Event Report: DIGITALDIAGNOST C90 HIGHPERFORMANCE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712034

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 doing an exam, the celling suspension with tube and collimator (cs) would get stuck and wouldn't move toward on the rails.The customer noticed that segments of the rail had lowered by about 5mm causing the collision.No injury occurred.

Manufacturer Narrative

Int ref: (b)(4).This digitaldiagnost c 90 high performance system is a direct digital radiography system with flat detector technology (fixed or mobile detectors) based on modular components to allow for customization for all radiographic applications and workload requirements.This radiography system is equipped with ceiling suspended column csm3 (carrying the x-ray tube, collimator and control handle) a bucky table, a bucky wall stand and a high tension generator cabinet for general x-ray examinations.The csm3 ceiling suspension is attached to the longitudinal ceiling rails and can be freely moved longitudinally and transversely.The two longitudinal ceiling rails and the extension rails of the csm3 are fixed to the ceiling sub construction anchor rails with clamping blocks at about every 1300mm (51 inch).The sub construction will be installed by a contractor prior to system installation by philips.The philips field service engineer (fse) has investigated on site.It was noticed that both longitudinal ceiling rails have lowered to the extended rails by 5mm and causing the collision.The fse checked all torque settings and coupling bars for the longitudinal ceiling suspension rails and extended rails and no issues were found.Also checked the fse the bolts and fixings of the sub construction and nothing was found to be loose.The contractor company ¿rcl services¿ has sent engineers which mounted additional ceiling fixture to the rails where the longitudinal ceiling rail and the extension rails meet.After a few runs of the csm3 it can be concluded that the system is safe to use.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.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.

• Brand Name: DIGITALDIAGNOST C90 HIGHPERFORMANCE
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• MDR Report Key: 12377306
• MDR Text Key: 268465370
• Report Number: 3003768251-2021-10011
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 00884838090699
• UDI-Public: 00884838090699
• Combination Product (y/n): N
• PMA/PMN Number: K182973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

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: 712034
• Device Catalogue Number: 712034
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/02/2021
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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