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

Model Number 712020

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

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 reported a broken hinge on the foot board for the patient support for stitching.This can lead to falling foot board and in worse case to a broken toe.No injury occurred.

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 enables 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 for transportation, e.G.From one room to another.Philips field service engineer investigated at site and confirmed the reported issue.One hinge of the footboard was broken for some reason, the footboard may folded up in a way that prevents the hook for snapping into place securely.Philips field service engineer installed an already initiated field safety corrective action (fco 71200185) which contains improvement of hinges and an additional brake cylinder and made sure that the equipment is working as specified.After implementation of the field safety corrective action the risk is estimated as acceptable risk.This issue is further monitored and trended.Correction: h6 result and conclusion.

• Brand Name: DIGITALDIAGNOST SINGLE DETECTOR
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• MDR Report Key: 11403797
• MDR Text Key: 234409454
• Report Number: 3003768251-2021-00004
• 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
• Remedial Action: Recall
• 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: 712020
• Device Catalogue Number: 712020
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/04/2020
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 05/25/2021
• 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
• Removal/Correction Number: Z 2863 2018
• Patient Sequence Number: 1