MAUDE Adverse Event Report: MED X CHANGE, INC CPU DIGITAL RECORDING SYSTEM 1080P; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Catalog Number DRSHD-1080P

Device Problems Fire (1245); Smoking (1585)

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

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

This report is being filed as a voluntary distributor report.The manufacturer med x change is responsible for performing evaluation, investigation and any remedial actions related to this reported device issue.

Event Description

This is a voluntary distributor report.The user facility contacted the conmed sales representative to report a fire in their operating room on (b)(6) 2017.It was reported that about mid-case during a gyn procedure the dvd drive of the cpu digital recording system 1080p was observed to be smoldering/smoking and had to be unplugged and removed from the room.The fire department was called.The procedure was completed using another cpu digital recording system 1080p.There was no patient or staff injury reported.A 15-minute delay was reported during the surgery due to the alleged malfunction and the need to remove the unit from the room and set up another recording system.As reported, when the fire department arrived at the user facility, the alleged smoldering/smoking from the dvd drive had ceased.

• Brand Name: CPU DIGITAL RECORDING SYSTEM 1080P
• Type of Device: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): MED X CHANGE, INC; 525 8th st w; bradenton FL 34205
• Manufacturer (Section G): MED X CHANGE, INC; 525 8th st w; bradenton FL 34205
• Manufacturer Contact: edwin martinez ; 525 8th st w; bradenton, FL 34205 ; 9417949977
• MDR Report Key: 6486051
• MDR Text Key: 72797179
• Report Number: 1017294-2017-00035
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DRSHD-1080P
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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