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

Model Number 712020

Device Problem Folded (2630)

Patient Problems Abrasion (1689); Hematoma (1884); 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

During movement of patient support, the foot support folded down onto nurse shin.Nurse has abrasions and hematoma on both shins.Minor injury occurred.

Manufacturer Narrative

(b)(4).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.The investigation revealed that both hinges had fully different signs of wear and tear.The result was that the footboard did not fit properly into the frame and additional pressure was needed to securely lock the hook.The replaced parts (hinges and hook) were sent back for investigation.They were mounted at a patient support in the development department and led to the investigation result.The hook showed no damage and worked as specified.The hinges and the hook were replaced.A capa was initiated and resulted in a remedial action (b)(4).The field remedial action contains improvement of hinges and an additional brake cylinder.Health professional instead of consumer.

• Brand Name: DIGITALDIAGNOST SINGLE 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; roentgenstr. 24; hamburg 22335 ; GM 22335 ; 405078-229
• MDR Report Key: 6979112
• MDR Text Key: 90897206
• Report Number: 3003768251-2017-00007
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• 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
• Patient Sequence Number: 1