MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. PRISM NUCLEAR GAMMA CAMERA SYSTEM

Model Number N215003

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2014, the customer reported that their prism 2000's gamma camera was acquiring a left and right lateral static views when unexpectedly the heads began to radius in without user intervention.The heads collided with the patient table.The technologist stopped the motions by removing power to the gantry through the main power button.The technologist retracted the heads after power up of the system without any errors and removed the patient from the table in a controlled manner.The philips field service engineer (fse) confirmed that there was no harm to the patient, operator, or bystander.The patient was moved to another camera within the department for a rescan.The camera was taken out of service and the philips help desk was notified to dispatch an fse for investigation.The trained operator's attempts to use the manual e-stop were unsuccessful.However, it is unknown if the operator attempted to use the e-stop after the power was shut off.On (b)(6) 2014, the fse arrived on site and evaluated the system.The fse confirmed that after the power cycle, all manual e-stop and collision detection circuitry for collimator faces were tested and proved to be operating.Therefore, it cannot be determined if the e-stop failed or if the collision detection circuitry on the collimator face failed to initiate an e-stop when the detectors encountered the patient pallet.Upon inspection, the fse noted the foot table pedestal was loose from the floor, which was due to the collision with the patient table.The detector 2 crystal was broken and lehr collimators on both detectors were damaged due to the collision with the patient table.There were no stuck buttons.The fse notified the user that the camera was to remain out of clinical use until parts could be replaced.The fse later confirmed that the camera needed to be decommissioned because of no availability of parts due to the camera being at end of life (eol) status.It was dismantled and removed from hospital on (b)(6) 2014.Per the prism ifu, quality control measures should be conducted prior to using the prism camera.On (b)(6) 2014 preventive maintenance for prism gamma camera and detector calibration was performed.Daily qc calibration was performed to verify uniformity of detectors and that it was within manufactured specifications.Further investigation by engineering was unable to be performed due to the logfiles not being available for analysis.No parts were returned for evaluation.In addition, the major components like the detector crystal and collimator have no availability due to the prism 2000's camera systems being eol.The camera was decommissioned and a cause undetermined due to a lack of information.Since there were no parts returned from the field or log files provided, a cause of the issue could not be determined by engineering.The mitigation's for this issue include: routine inspection through service pm and/or customer pm documentation.Reflecting required inspection of mechanics and hardware limits.Service and operator documentation reflecting detailed corrective actions for specific radius motion failure modes.Install warning labels on service override switches and system covers reflecting only qualified service personnel should remove equipment covers and perform maintenance, repairs or any corrective measures.The camera was decommissioned because of no availability of parts due to the camera being at end of life (eol) status.It was dismantled and removed from the hospital on (b)(6)2014.

Event Description

The customer reported that their prism 2000's gamma camera was acquiring a left and right lateral static views when unexpectedly, the heads began to radius in without user intervention.The heads collided with the patient table.The technologist stopped the motions by removing power to the gantry through the main power button.She retracted the heads after power up of the system without any errors and removed the patient from the table in a controlled manner.The trained operator's attempts to use the manual e-stops were unsuccessful.Collision detection circuitry on the collimator face failed to initiate an e-stop when the detectors encountered the patient pallet.The philips field service engineer (fse) confirmed that there was no harm to the patient, operator, or bystander.The patient was moved to another camera within the department for a rescan.The camera was taken out of service and the local help desk was notified to dispatch an fse for investigation.The powering off of the system eliminated all logs of the event, thus preventing further investigation.Confirmation was received from the fse that after the power cycle, all manual e-stop and collision detection circuitry for collimator faces were tested and proved to be operating.Upon inspection, the fse noted the foot table pedestal was loose from the floor, which was due to the collision with the patient table.The detector 2 crystal was broken and lehr collimators on both detectors were damaged due to the collision with the patient table.There were no stuck buttons.The fse notified the user that the camera is to remain out of clinical use until parts could be replaced.

• Brand Name: PRISM NUCLEAR GAMMA CAMERA SYSTEM
• Type of Device: GAMMA CAMERA SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: dan brown ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 5220984
• MDR Text Key: 31180844
• Report Number: 1525965-2015-00288
• Device Sequence Number: 1
• Product Code: IYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N215003
• Device Catalogue Number: 88201
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 11/12/2015
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1