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

Model Number 728231

Device Problem Unintended Movement (3026)

Patient Problems Head Injury (1879); Injury (2348)

Event Type  Injury  

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; the customer reported that two third party service engineers were replacing the encoder belt on the ct system when the table dropped down.The safety bar was not utilized during repair and therefore, when the table dropped, one engineer's finger was injured (addressed in (b)(4)) and the other¿s head was injured (addressed in (b)(4)).At this time there is no indication that a malfunction has occurred.

Manufacturer Narrative

On (b)(6) 2017, the customer reported that while servicing the couch to replace the vertical encoder belt, their service engineers (se) did not install the green safety bar, which allowed the couch to collapse when the vertical drive motor was detached to add the encoder belt.This complaint is for the service engineer whose finger was injured.There was no patient impact as this occurred during servicing of the system.The customer¿s se received light injuries resulting in a hematoma on a finger.There were no broken bones and no stitches were required.There was no serious injury and no malfunction of the system.A philips compliance specialist (pcs) reported that after the couch fell, the customer¿s se's completed the installation of the vertical encoder belt and reinstalled the vertical drive motor to restore system operation.The patient support repair and replace manual clearly 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 the customer¿s service engineer¿s error.The se did not follow the service instructions by not installing the green safety bar during servicing of the ct system involving raising the ct couch.The system is operational and in clinical use.

• Brand Name: BRILLIANCE 64
• 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: 6381061
• MDR Text Key: 69170646
• Report Number: 1525965-2017-00010
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K033326
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 728231
• Device Catalogue Number: NCTB423
• 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: 02/27/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• 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