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

Model Number 728244

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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).

Event Description

A philips field service engineer (fse) observed, during a scheduled planned maintenance (pm), that the bariatric flat top was sitting unsecured to the patient support.The fse confirmed there was no harm to a patient, operator, or bystander associated with this issue.The fse evaluated the ct system and determined that the front wedge clips, that secures the therapy top to the patient support, were missing and the right front corner of the bariatric flat top was damaged.The fse replaced the bariatric flat top to resolve this issue).

Manufacturer Narrative

On 03-aug-2015, the philips field service engineer (fse) observed during a scheduled planned maintenance (pm) that the bariatric flat top was sitting unsecured to the patient support.The fse confirmed there was no harm to a patient, operator, or bystander associated with this issue.The fse evaluated the ct system and determined that the front wedge clips that secure the therapy top to the patient support were missing and the right front corner of the bariatric flat top was damaged.It was communicated that based upon the fse's evaluation of the damaged table top, the fse stated that it was most likely caused by the customer lowering the table top onto a gurney/metal table they use to load patients on the system.The fse confirmed that there was noticeable damage on the right side of the broken table top where a collision had occurred.It was also confirmed by the fse that the table top was still secured to the table on the foot end of the table by the 2 screws.The broken table top was requested to be sent back for engineering evaluation, but it was confirmed by the philips fse, that the customer discarded the broken table top before the fse arrived to replace with a new bariatric table top.No parts were available to be sent back for evaluation.The philips fse installed a new bariatric flat top to resolve the reported issue at the customer site.Ct engineering determined this event to be acceptable risk.It has been concluded that if this event were to recur it would not be likely to cause or contribute to death or serious injury.Due to the defective part and log files not being available for engineering evaluation, a cause could not be determined.The probable cause of this event, based on the information provided by the philips fse, is that the customer lowered the bariatric flat carbon top into a patient gurney/table causing the damage to occur.

• Brand Name: BRILLIANCE BIG BORE RADIOLOGY
• 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: 5034878
• MDR Text Key: 25113914
• Report Number: 1525965-2015-00233
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728244
• Device Catalogue Number: NCTB604
• 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
• Date Manufacturer Received: 08/03/2015
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1