MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH EASYDIAGNOST ELEVA DRF; SYSTEM, X-RAY, STATIONARY

Model Number 706050

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

Customer reports a broken hinge on patient support for stitching.No injury occurred.

Manufacturer Narrative

Int.Ref.8846826.The easydiagnost system supports general radiography and fluoroscopy imaging.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.If the both hinges of the footboard are for some reason worn differently, the footboard may folded up in a way that prevents the hook for snapping into place securely.Philips field service engineer replaced both hinges and made sure that the equipment is working as specified.An already initiated field safety corrective action (fco 71200185) contains improvement of hinges and an additional brake cylinder.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: EASYDIAGNOST ELEVA DRF
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 8230712
• MDR Text Key: 132503449
• Report Number: 3003768251-2019-00002
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K031535
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 706050
• Device Catalogue Number: 706050
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2863-2018
• Patient Sequence Number: 1