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 Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 complained that the brake cylinder broke out of the frame of the patient support for stitching.The brake cylinder prevents the footboard of the patient support for stitching from falling down unexpected.No injury occurred.

Manufacturer Narrative

Int.Ref.10011642 the digitaldiagnost is a direct digital radiography system with flat detector technology based on modular components to allow for customization for all radiographic applications and workload requirements.The patient support for stitching is an accessory that allows the examination of full leg or full spine with the patient standing upright.For easy use, the patient support for stitching has wheels and a folding footboard.The footboard is connected to the frame via two hinges and a break cylinder and has to be folded up and fixed by a hook (plastic clip) for transportation, e.G.From one room to another.The brake cylinder has the task to ensure that the footboard lowers itself slowly (within 5 7 seconds) when the hook is released, to prevent the footplate from falling on the foot of a person.If the operator steps on the footboard while it is still moving down, the mounting of the brake cylinder can break and the footboard fell down immediately.Philips field service engineer investigated at site.The hospital radiographer states that the issued happened when he let the foot board down, without stepping on it.However the capa investigation shows that a breaking of the fixation of the brake cylinder is not possible without additional external forces, therefore use error.Furthermore it was concluded that the risk is acceptable per risk benefit determination.Philips field service engineer replaced the complete patient support for stitching against a newer version.This issue is further monitored and trended.Correction: h6 result and 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 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: 9437548
• MDR Text Key: 181521994
• Report Number: 3003768251-2019-00020
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

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: 11/19/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1