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 Unintended Movement (3026)

Patient Problem Injury (2348)

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 reported that the footboard of patient support for stitching was released and it came down too fast.It hit operators toe.The toe was not broken, it was only bandaged.

Manufacturer Narrative

Int.Ref: (b)(4).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 has to be folded up and fixed by a hook (plastic clip) for transportation, e.G.From one room to another.The philips healthcare field service engineer has investigated at site and talked to the operator who had the accident.According to the operator, nothing was broken and they did not put stitches in.They just bandaged it and is now healing well.He identified that the latest fco71200185 to prevent the footboard from accidentally falling down was not installed at this patient support for stitching.Philips field service engineer ordered and installed an already initiated field safety corrective action (fco 71200185) for the patient support for stitching which contains improvement of hinges and an additional brake cylinder.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 footboard from falling.After implementation of the field safety corrective action the risk is estimated as acceptable risk.This issue is further monitored and trended.Correction: h6 results 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 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: 8910147
• MDR Text Key: 155180825
• Report Number: 3003768251-2019-00014
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

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: 07/22/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2843-2018
• Patient Sequence Number: 1