MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 3.0.X; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712025

Device Problem Device Inoperable (1663)

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

When the customer tried to lock the footboard in the upright position, the customer detects that the plastic hook did not work anymore.Further investigation of the customer determined that the hinges were loose.No injury occurred.

Manufacturer Narrative

The patient support is an accessory that enables the examination of full leg or full spine, with the patient standing upright.For ease of use, the stand 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.No philips field service engineer was at site to investigate the issue.However, the investigation result of the development is that if the two hinges are for some reason not equally worn, the footboard may tilt in a way that prevents the hook for snapping into place, unless substantially more force is applied on the footboard.This result corresponds to the description of the customer and explains that the customer does not report any further issues after the hinges have been replaced.The user ordered the hinges and repaired the patient support by himself.A capa was initiated and resulted in a remedial action ((b)(4)).The remedial action contains improvement of hinges and an additional brake cylinder.Correction: results and conclusions 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 3.0.X
• 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: 7573640
• MDR Text Key: 110585912
• Report Number: 3003768251-2018-00003
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 712025
• Device Catalogue Number: 712025
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1