MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRIGHTVIEW XCT; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Catalog Number 882482

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4) note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.

Event Description

The customer reported that while attempting to move the collimator exchange cart, which contained the high energy general purpose (hegp) collimators, the hegp for detector two (2) fell to the floor after being removed from the head of detector 2.The hegp collimator from detector 2 came in contact with the operator's foot causing an injury to one of their toes.

Manufacturer Narrative

(b)(4).The customer reported that while attempting to move the collimator exchange cart containing the high energy general purpose (hegp) collimators, the hegp for detector two fell to the floor after being removed from the head of detector two.The hegp collimator from detector two came in contact with the operator¿s foot causing an injury to one of their toes.There is no patient involvement during collimator exchange.The third party field service engineer (fse) was contacted and arrived onsite to evaluate the system.The fse attempted to reproduce the issue, however, was not successful.The fse reported that prior to his arrival, the damaged collimator was moved to a safe position and another set of collimators had been loaded onto the detectors.When the fse arrived at the customer site, the system had a permanent collision on detector one due to a damaged auto body contouring (abc) collision interface board which was caused by the hegp collimator that had fallen on the floor.The fse spoke to the hospital staff regarding what occurred during the incident.The hospital staff stated that the collimator was resting upright against the cart with the other collimator securely in the cart.The customer alleged that the system then began to unlock the collimator cart causing the collimator to fall flat on the floor, damage the corner board, and cause the injury to the operator's toe.The fse returned the next day and replaced the corner board on detector one, then performed tests including several collimator exchanges.The fse reported that no problems were encountered.The fse could not provide further details regarding the injury other than the operator's toe was injured.Additional attempts were made by the fse to obtain information from the customer regarding the injury to the operator and details of the event; however, no information was provided.The log files were collected at the site and sent to philips software engineering for evaluation.A phillips software engineer reviewed the log files and confirmed that there was no indication a software failure occurred.The logs showed several instances of successful exchanging of hegp and low energy high resolution (lehr) collimators leading up to the incident.The software engineer confirmed that all indications show that the system performed the collimator exchange correctly.The fse was not able to reproduce the issue on the system.The fse confirmed that a new collimator set was replaced on (b)(6) 2016.

Manufacturer Narrative

New follow-up information was received on 02-nov-2017 confirming the operator received a fracture to their left, big toe.The operator has since returned to regular work duties.

• Brand Name: BRIGHTVIEW XCT
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: chris smith ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 5806476
• MDR Text Key: 49914655
• Report Number: 1525965-2016-00029
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 882482
• 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
• Date Manufacturer Received: 07/10/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1