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

Model Number 728243

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.(b)(4).

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The philips field service engineer (fse) alleges the safety labels for the clutch and motor on the table are inadequate.At this time there is no indication that a malfunction has occurred.

Manufacturer Narrative

On (b)(6) 2017, a philips field service engineer (fse) reported that during servicing of a philips big bore (bb) oncology ct system, the couch collapsed, descending downward.The fse confirmed that there was no harm to a patient, operator, or bystander as a result of this issue.The fse stated that the green safety bar was not utilized when raising the ct couch to perform service.The patient support repair and replace manual states: "warning: install the vertical safety support brace whenever personnel are working under the table.Failure to do so may result in personnel injury or death." the cause of the couch descending downward has been determined to be fse error.The fse did not follow the service instructions by not installing the green safety bar during servicing of the ct system involving raising the ct couch.

• Brand Name: BRILLIANCE BIG BORE ONCOLOGY
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• 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: 6380895
• MDR Text Key: 69412744
• Report Number: 1525965-2017-00009
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033357
• 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
• Report Date: 02/16/2017

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: 728243
• Device Catalogue Number: NCTB104
• 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
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• 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