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

Catalog Number DRSHD-1080P

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2017

Event Type  malfunction  

Manufacturer Narrative

As of this filing, the cpu digital recording system 1080p has not yet been returned from the user facility for evaluation.A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.

Event Description

The user facility contacted the sales representative to report a fire in their operating room on (b)(6) 2017, late in the evening when the room was not in use.It was reported that around 11:00 pm someone walking by the surgery room noticed that the (drshd-1080p) cpu digital recording system 1080p was on fire.The dvd was smoldering and burned the unit.The cpu digital recording system 1080p was connected to a boom.The fire department was called in and the fire extinguished.There was no patient involvement and no harm reported to the hospital staff or patients.

• 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: brenda johnson ; 525 french road; utica, NY 13502-5994 ; 7273995169
• MDR Report Key: 6430356
• MDR Text Key: 70900797
• Report Number: 1017294-2017-00029
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DRSHD-1080P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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