MAUDE Adverse Event Report: BUCKY DIAGNOST TH; SYSTEM, X-RAY, STATIONARY

Model Number 704030

Device Problem Protective Measures Problem (3015)

Patient Problem Tooth Fracture (2428)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

Ref.Id: (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

The customer complained that when moving the x-ray tube (which is located on a telescopic arm on a ceiling suspension) by pressing the "release all brakes" button on the operating handle, the tube suddenly stopped, the operator ran against the handle, resulting in the breakage of a tooth.

Manufacturer Narrative

Ref.Id:(b)(4).This bucky diagnost th system is a radiography system with ceiling suspended column (cs 2/4), a height adjustable bucky table (th) and a high tension generator cabinet for general x-ray examinations.The cs 2/4 carrying the x-ray tube, collimator and control handle and allows the freedom for a wide range of longitudinal, transverse and vertical movements (manually) in the examination room.Pre-defined exposure positions for the cs 2/4 can be set with a lock (detent) in the ceiling rails by field service engineer (fse) according to the local requirements.The required position (also outside the locking positions) is additionally held by a static electromagnetic brake.To release the electromagnetic (static) brake the corresponding push button on the control handle must be pressed.There is also a central push button on the control handle to release all 3 brakes (longitudinal, transverse and vertical) and locking position at the same time.After releasing the corresponding push button, the static brake is engaged again and the cs stops immediately.The philips field service engineer (fse) has investigated at site.The hospital staff reported that the cs 2/4 unexpectedly stopped during manual movement and an operator collided with his head (mouth) against the control handle.One of the operator's teeth broke off (moderate injury occurred).The affected operator required dental treatment.According the hospital staff this was not a stop in one of the position detents.The fse checked the movements of the cs 2/4 in all direction without any failure.He was not able to reproduce an unexpected movement stop.No failure found.The cause for the unexpected movement stop was not identified but most probably the unexpected stop occurred due to inattention of the operator (user error).Risk estimation revealed acceptable risk per risk benefit analysis.This issue is further monitored and trended.Correction: h6 results and conclusions code.

Event Description

The customer complained that when moving the x-ray tube (which is located on a telescopic arm on a ceiling suspension) by pressing the release all brakes button on the operating handle, the tube suddenly stopped, the operator ran against the handle, resulting in the breakage of a tooth.

• Brand Name: BUCKY DIAGNOST TH
• Type of Device: SYSTEM, X-RAY, STATIONARY
• MDR Report Key: 7969201
• MDR Text Key: 123831222
• Report Number: 3003768251-2018-00008
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K945278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 704030
• Device Catalogue Number: 704030
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2018
• 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
• Patient Outcome(s): Other