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

Model Number 706050

Device Problem Component Falling (1105)

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

During application training the wireless portable detector has dropped down from the trolley during change of the detector position.

Manufacturer Narrative

The easydiagnost system is equipped with a mobile holder (trolley) for the wireless portable detector.The mobile holder is designed to take full advantage of the wireless portable detector to perform free exposures in optimal conditions.The defect trolley was sent back to manufacturer for investigation.The investigation results in a modification of the detector clamping mechanism.Philips recall #: fco71200174.

• 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
• 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: 6120868
• MDR Text Key: 60904523
• Report Number: 3003768251-2016-00009
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 706050
• Device Catalogue Number: 706050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2016
• 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