MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRILLIANCE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number BRILLIANCE 64 UPGRADES

Device Problems Moisture or Humidity Problem (2986); Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

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 (b)(4).Date of report: 20220114.

Event Description

This complaint has been evaluated based on the information provided.The issue reported was that when the operator was pressing the gantry panel with their finger to move the table, the e-stop opened and the operator alleged they received a shock.The extent of the alleged injury is not known at this time.Based on the available information, this issue has been determined to be a reportable event.This event is currently under investigation.

Event Description

On (b)(6) 2021, the operator's foot made contact with the base of the table, the emergency stop (e-stop) opened (unknown cause) and the operator alleged they received a shock.The technician then walked to the emergency room (er) for observation but was not admitted.Multiple attempts were made to verify the extent of the alleged shock, however, the customer did not respond nor provide additional information.Engineering reviewed the information within this complaint record.The identified issue would not raise harm of electrical shock to a patient, operator, bystander, or service personnel.The humidity in the gantry room was 19%.This is significantly lower than the philips specification range (35%-70%).The shock the operator most likely received is human body electrostatic discharge (esd).Therefore, this issue has been determined to not be a reportable event.

Manufacturer Narrative

Additional manufacturer narrative: on 20-dec-2021, the operator's foot made contact with the base of the table, the emergency stop (e-stop) opened and the operator alleged they received a shock.The operator then walked to the emergency room (er) for observation but was not admitted.Multiple attempts were made to verify the extent of the alleged shock, however, the customer did not respond nor provide additional information.On 22-dec-2021, the philips field service engineer (fse) reported to the site to inspect the couch and gantry grounding cables for defects.Further investigation was performed to verify that grounding was installed according to philips requirements.The fse also checked for loose or damaged cables in couch.No defects with the couch or gantry grounding cables were identified that would cause shock as described by the operator.On 05-jan-2022, the fse along with the hospital's electrician and 3rd party service organization, performed an electrical audit on the incoming power and internal power and grounding cables which found the humidity in the gantry room was at 19% which is below philips humidity specification which is 35% to 70%.There is no information that the site has addressed the humidity issue.Philips engineering reviewed the information available and concluded: extent of injury (alleged shock) is unknown, the operator walked to the er (emergency room) for observation only and was not admitted.One occurrence reported by the customer.The fse and iss (3rd party service organization) confirmed no defects were found that would cause the alleged shock.The air was too dry (actual humidity is around 17% ~ 19%, proper humidity requirement per philips specification is 35% ~ 70%) which could contribute to human body electrostatic discharge (esd).Therefore, the alleged shock the operator received was likely esd due to the humidity issue.Probable cause: use error - failure to maintain philips recommended room humidity level.This event reported did not pose risk to health to patients, users, or bystanders, did not allege a serious injury or death and would not cause or contribute to a serious injury or death if the reported issue recurred.Therefore this event is not considered reportable.Internal cross reference: complaint pr# (b)(4).Date of report (b)(4).

• Brand Name: BRILLIANCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: beth johnson ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 13258838
• MDR Text Key: 283830608
• Report Number: 3015777306-2022-00001
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838083325
• UDI-Public: 00884838083325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BRILLIANCE 64 UPGRADES
• Device Catalogue Number: 728231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• 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 Outcome(s): Other