MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKY DIAGNOST TS; SYSTEM, X-RAY, STATIONARY

Model Number 704020

Device Problem Device Tipped Over (2589)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.(b)(6).

Event Description

The customer complained that the buckydiagnost ts column tipped over to the right side.No injury reported.

Manufacturer Narrative

The bucky ts is an x-ray system with a floor mounted stand together with a bucky table.The ts column (carrying the x-ray tube, collimator and control handle) has a tripod counterbalanced unit base.It is movable in longitudinal direction on two floor rails behind the bucky table.The local philips field service engineer visited site and confirmed issue.He took pictures of tipped column.Philips manufacturing site (b)(4) has requested the damaged parts for detailed technical investigation.The customer has declined to provide the defective parts from the room.Therefore root cause could not be finally identified.Corrected data: device available for evaluation (changed from yes to no).(b)(4).

• Brand Name: BUCKY DIAGNOST TS
• 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: 5959680
• MDR Text Key: 55351999
• Report Number: 3003768251-2016-00006
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945278
• 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 704020
• Device Catalogue Number: 704020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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