MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 16 AIR; COMPUTED TOMOGRAPHY X-RAY

Model Number 728246

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that the pallet (ct table top) was floating freely.A philips field service engineer (fse) confirmed this issue occurred while the ct system was not in clinical use and there was no harm to a patient, operator, or bystander as a result of this issue.The fse evaluated the ct system and determined that the table was mechanically disengaged from the drive and the three connecting screws were loose.The fse disassembled the ct table and found paper particles within the table, cleaned the ct table, tightened the screws, and engaged the ct table so it was working within specification.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).On (b)(6)-2015, the customer, (b)(6), reported that the pallet (ct table top) was floating freely, for (b)(4).The system was not in clinical use when the issue was discovered.There was no report of any harm to the operator, patient or bystander during the incident.The customer contacted the philips help desk to inform them of the issue.The philips field service engineer (fse) was dispatched to the site.The fse arrived at the site and evaluated the system.The fse determined that the table top was mechanically disengaged from the drive, due to the three connecting screws being detached.No information could be obtained on why the screws were loose.The fse disassembled the ct table and also found paper particles within the table.The fse then cleaned the ct table, re-secured the screws, so that the ct table was attached to the horizontal drive and working within specification.No similar complaints have been received from the customer after the connecting screws were re-secured.Ct engineering determined this issue to be an acceptable risk with the following mitigations for this issue : service personnel are trained to engage the service latch properly during any service activities that require opening of the gantry front cover.¿ floating table can be detected by trained personnel during loading/unloading a patient for scanning or loading a phantom for qa checks.A.Brilliance ct ifu (v2.3) section 1.10 (¿training¿).¿ execution of qa checks per user instructions enables detection of table position errors when loading or unloading phantom.A.Brilliance ct ifu (v2.3) section 4.4 (¿daily checks¿).¿ service personnel are instructed to perform auto iq tests (acceptance/constancy and/or quick iq tests) after installation, preventive maintenance (pm), and corrective actions.A.Br 16/16p iq and dose testing instructions (section 1 - introduction).B.Br 16/16p iq and dose testing instructions (sections 5 & 6, table 3).C.Execution of auto iq tests, per service instructions, enables detection of table position errors.D.Br 16/16p iq and dose testing instructions (section 1 - introduction).E.Br 16/16p iq and dose testing instructions (sections 5 & 6, table 3).¿ for oncology usage, positional accuracy testing using the therapy top calibration phantom enables detection of table position errors.A.Brilliance ct therapy table top installation instructions p.17.B.Brilliance therapy table top installation instructions p.10.¿ during a helical scan, per design, cirs shall verify the couch is moving in the direction specified by the host and shall stop the acquisition if the couch positions are not updated as expected.The fse determined that the table was mechanically disengaged from the drive due to the three connecting screws being detached.However, the fse could not determine the cause of the loose screws.Thus, a root cause could not be determined.

• Brand Name: BRILLIANCE 16 AIR
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: nancy drake ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 4767081
• MDR Text Key: 5949115
• Report Number: 1525965-2015-00132
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K012009
• 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
• Report Date: 04/13/2015

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: 728246
• Device Catalogue Number: NCTA399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• 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
• Patient Sequence Number: 1