MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Unintended System Motion (1430); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that while a patient was on the table, a strange noise was heard and then the bed dropped to its lowest position.There is no allegation of death or serious injury.

Manufacturer Narrative

On (b)(6) 2016, the customer reported that during the vertical movement of the bed, prior to an acquisition, a strange noise was heard and suddenly the bed dropped to the lowest position with a (b)(6) patient on the table.The field service engineer (fse) confirmed there was no report of injury to the patient, operator or bystander.The patient was moved to a different system and scanned.The fse arrived at the customer site to evaluate the system.The fse confirmed the issue when diagnosing the system.The fse diagnosed the system and determined the vertical brake failed on the couch.The fse confirmed that the patient was loaded onto the couch and was being moved in the vertical up motion when the reported event occurred.The fse stated that the lead screw was not broken or cracked.The fse ordered the couch vertical motor brake assembly and replaced the part at the customer site.The fse confirmed there are no log files or bug reports available and that the failed part has been scrapped; therefore, it was not available for a failure analysis.The fse replaced the couch vertical motor brake assembly to resolve the issue.The fse determined the probable cause to be a failed vertical brake.The fse confirmed the system is working as specified.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: 6004583
• MDR Text Key: 57174375
• Report Number: 1525965-2016-00035
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 09/22/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1