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

Model Number 712055

Device Problems Folded (2630); Unintended Movement (3026)

Patient Problem Ecchymosis (1818)

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 adjusting the drive handle at the stand the stretch grip bracket folded down and hit a nurse on her head resulting in a bruise.Minor injury occurred.

Manufacturer Narrative

The digital diagnost is a direct digital radiography system, equipped with ceiling suspended column (carrying the x-ray tube) and a vertical wall stand (vm) for general x-ray examinations.The stretch grip is a wall stand option to make patient positioning more comfortable.The patient can hold the grip with the hands in order to have the arms out of the way of the anatomy under examination.With the swiveling function of the stretch grip, it is possible to adjust its height to the patient's height, this is possible by pulling the grip (releasing a spring loaded toothed clutch lock).A philips healthcare field service engineer has investigated at site and it seemed to him, that it was the locking spring.The stretch grip was replaced and the stretch grip was sent back to manufacturer for investigation.The development department engineer has found signs of unauthorized manipulation of the stretch grip.

Event Description

When adjusting the drive handle at the stand, the stretch grip bracket folded down and hit a nurse on her head resulting in a bruise.

• Brand Name: DIGITALDIAGNOST VM
• 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: 6484881
• MDR Text Key: 72790467
• Report Number: 3003768251-2017-00003
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K982795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 712055
• Device Catalogue Number: 712055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2017
• 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