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

Model Number 728246

Device Problem Positioning Problem (3009)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

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

This complaint has been evaluated based on the information provided.The customer reported that upon tilting the gantry for a patient procedure, the gantry cover opened and came into contact with the patient¿s knee.This resulted in an injury to the patient¿s knee, which required medical intervention and sutures.This event is currently under investigation.

Manufacturer Narrative

During a (b)(6)-year old patient¿s lumbar procedure, when the gantry was tilted, the top of the gantry front cover came free from the top of the gantry and fell on the patient.The patient received a wound near the knee, which required 7 stitches.The patient was hospitalized for monitoring.A philips field service engineer (fse) evaluated the system and determined that the adhesive securing the gantry front cover to the metal bar had failed, allowing the front cover to be free at the top.This also damaged the gantry display/ switch controller board.The fse replaced the front cover and the gantry display/switch controller board.The system is operational and in clinical use.

• 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: derrick massuri ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 6852967
• MDR Text Key: 85444454
• Report Number: 1525965-2017-00017
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012009
• 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: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728246
• Device Catalogue Number: NCTA399
• 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: 09/07/2017
• 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
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 40