MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRIGHTVIEW; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number BRIGHTVIEW XCT

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr3064162.

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported a finger laceration was obtained from an internal fan on the brightview xct generator while putting a usb in the reconstruction computer to get log files.Medical intervention was administered in the emergency room (er).The laceration was treated with skin glue and a splint applied to the area.Based on the available information, it is unknown if the reported event would be likely to cause or contribute to a death or serious injury if it were to recur.Therefore, this event is being reported conservatively.Philips has started an investigation of this complaint.

Manufacturer Narrative

Final: the customer reported a finger laceration was obtained from an internal fan on the brightview xct generator while putting a usb in the reconstruction computer to get log files.While onsite to evaluate an x-ray issue, a recently trained philips field service engineer (fse) directly accessed the brightview reconstruction (bvrecon) computer to pull logs by connecting a usb drive stick with the generator powered on.While accessing the usb port, the fse's finger contacted the adjacent rotating fan causing a minor laceration.Medical intervention was administered in the emergency room (er).The laceration was treated with skin glue and a splint applied to the area.The fse returned to work right after being released from the er.The system was outside of clinical use during this event.Philips engineering reviewed the event details and determined the newly trained fse directly accessed the bvrecon computer with the generator powered on.Per the brightview service tools, diagnostics, and remote service manual: prior to any service and maintenance activities inside components: ¿ switch off the system at the main power supply, and the uninterruptible power supply (ups).¿ use lockout/tagout (loto) procedures to safeguard against the release of hazardous energy during installation, maintenance or service work on the system.¿ always use an esd protection wrist strap when servicing any component in the system.Also, per the manual: service is instructed to access the xct recon computer logs by logging into the acquisition client computer to access the philips support connect (psc) tool without opening the generator back cover or directly accessing the bvrecon.In this case, the bvrecon was directly assessed by the fse with the generator powered on.Conclusion: the probable cause of this issue was use error.The fse opened the bvrecon computer to expose motorized component movements (rotor fan) as an alternate to logging into the acquisition client computer to access the psc tool as instructed in the brightview service tools, diagnostics, and remote service manual.Therefore, this has been concluded to not be reportable.The codes were updated based on the investigation outcome: problem code evaluation method code h3 other text: not a device issue, use error issue.

• Brand Name: BRIGHTVIEW
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: beth johnson ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16454838
• MDR Text Key: 310372735
• Report Number: 3015777306-2023-00003
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080927
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BRIGHTVIEW XCT
• Device Catalogue Number: 882454
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 77 KG