MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. VERTEX EPIC MCD; GAMMA CAMERA SYSTEMS

Model Number 2154-3000A

Device Problems Mechanical Problem (1384); Inadequate Service (1564)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

In this case, an operator was performing a scan when they noticed that detector one drifted in a downward motion on the vertex camera.There is no report of the operator having to repeat the scan on the patient.A service call was placed for the local philips field service engineer (fse).The philips fse evaluated and found grease had gotten into the radius clutch/brake assembly on detector one.The philips fse tested the radius gear box and belt to find them in working order.The philips fse ordered two radius clutch assemblies and replaced the necessary parts on the system.Further information provided by the philips field service engineer indicates that this event die not occur during a patient procedure.This event occurred during a quality assurance test with no patient involvement.

Manufacturer Narrative

The technologist noticed on (b)(4) 2013 that detector 1 drifted in a downward motion during quality assurance testing and contacted philips service.There was no injury to patient, operator or bystander.There was no incidence of rescan or reinjection of a patient.On 20-aug-2013 philips service investigated the system by performing a test.The fse placed the detector in a 180 degree configuration with head #1 at the bottom with the high energy general purpose (hegp) collimator installed.He stated that after they tested and examined the system they were able to confirm that detector 1 would drift down when the high energy general purpose collimators were in utilized.After clutch replacement the same testing was performed and the detector no longer drifted.Upon further investigation of the system by the philips service grease was found on one of the clutches.The biu engineer who was investigating a similar incident, documented in a previous complaint, was informed of the event and conducted a telephone interview with the primary fse for the customer site, which confirmed this complaint to be the same issue with the same probable root cause.The description of the reported issue and the interview is documented in the vertex clutch failure engineering investigation report.The fse explained that he tested the radius gear box and the belt.The gearbox and belt tests passed.When he tested the radius brake/clutch assembly he found the clutches to be slipping a small amount.He found grease in the radius assembly clutch/brake assembly which was of an oily consistency.Engineering stated that there are different possible scenarios for the clutches to get contaminated: grease on ball screw drifted down to the clutches due to heat and gravity over time.Oil in the gearbox got into the clutches (unlikely).Grease/oil was applied to clutches or components close to the clutches, e.G.Bearings.Solvent (e.G.Wd 40) was applied to clean" the clutches.Further investigation into the preventative maintenance {pm) procedures found that the clutches are required to be inspected every three months and to replace if contaminated.Pm procedure requires the clutches to be inspected every 3 months, and replaced if contaminated.Vertex inspection, testing and replacement of radius drive clutch vtx-52 specified the acceptable criteria: 1cm/min with drive belt removed (held by clutches only).Engineering investigation concluded the following: the clutches were contaminated by external oil/grease.Oil and/or grease contamination in conjunction with clutch wear and tear over time caused the clutches failure.Contaminated clutches were not replaced as required in the service pm procedure.Clutch inspection instructions in current pm procedure are subjective.Investigation determined that the overall risk for this issue is acceptable and if it were to recur would not be likely to cause death or serious injury because: design of the drive system prevents free-fall drop of the detector and limits the rate of travel in non-user initiated downward movement through counterforces provided by associated components (motor, gearbox, belt pulleys, ball screws, linear bearing, etc.) when one or more components fail.Product ifu instructs the operator to monitor the patient during scan.The operator can enter manual override mode prior to the detector drifting more than 4cm and before the limit switch is triggered.Manual override mode allows operator to move up detector head away from patient, to translate the gantry away from patient and to lower the patient pallet so that patient can be removed.If the detector comes into contact with a patient, the collision alarm is activated to alert the operator, including an audible warning beep and illuminating the emergency stop lights.Product ifu provides instructions on emergency patient removal.On (b)(4) 2013 philips fse replaced the clutches and scrapped the contaminated parts.The system was tested and returned to the customer.Internal cross reference: (b)(4).

• Brand Name: VERTEX EPIC MCD
• Type of Device: GAMMA CAMERA SYSTEMS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: nancy drake ; 595 miner rd.; cleveland, OH 44143 ; 4404831169
• MDR Report Key: 4645685
• MDR Text Key: 5685116
• Report Number: 1525965-2014-00161
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2154-3000A
• Device Catalogue Number: 88297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2013
• 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