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

Model Number 728246

Device Problems Mechanical Problem (1384); Positioning Problem (3009); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that while positioning a patient vertically the patient support moved to its lowest vertical position uncommanded.The philips field service engineer (fse) reported there was no harm to the patient, operator or bystander.The fse evaluated the ct system and determined that the patient support would not stay at its highest position and drifted down to its lowest position uncommanded.The fse found two loose screws on the motor shaft coupling on the vertical motor brake assembly which was not holding the brake disc in place, and tightened the screws to resolve the issue.The fse has ordered a new brake assembly and has replaced the encoder drive belt.

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.(b)(4).

Manufacturer Narrative

(b)(4).On (b)(6) 2015, the customer reported that while positioning a patient vertically, the patient support moved to its lowest vertical position uncommanded.The philips field service engineer (fse) reported there was no harm to the patient, operator or bystander.The fse evaluated the ct system and determined that the patient support would not stay at its highest position and drifted down to its lowest position uncommanded.The fse found two loose screws on the motor shaft coupling on the vertical motor brake assembly that was not holding the brake disc in place, as well as, a loose spline key.The fse tightened the screws to secure the brake disc to the motor shaft and ordered a new brake assembly to resolve the issue.Communication with the fse on site stated that there appeared to be a lack of loctite present when he arrived to evaluate the issue.Philips ct engineering confirmed that if loctite was not applied properly or not applied at all, then the symptoms seen at this site could be a result (the vertical motor assembly connecting pin being broken and loose).On 26-jun-2015, the fse installed a new brake assembly and replaced the encoder drive belt to resolve the issue; he confirmed he used loctite.Since there were no log files and no parts returned for further analysis, a cause could not be determined.Investigation performed by the fse onsite states probable cause is lack of loctite on the set screws.

Event Description

The customer reported that while positioning a patient vertically, the patient support moved to its lowest vertical position uncommanded.The philips field service engineer (fse) reported there was no harm to the patient, operator or bystander.The fse evaluated the ct system and determined that the patient support would not stay at its highest position and drifted down to its lowest position uncommanded.The fse found two loose screws on the motor shaft coupling on the vertical motor brake assembly which was not holding the brake disc in place, and tightened the screws to resolve the issue.The fse has ordered a new brake assembly and has replaced the encoder drive belt.

Manufacturer Narrative

Corrected manufacturer's contact person information.

• 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; 400 s. 28th ave.; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 4802479
• MDR Text Key: 20728978
• Report Number: 1525965-2015-00145
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2015

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: 04/28/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2016; 04/14/2016
• 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
• Patient Sequence Number: 1