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U.S. Department of Health and Human Services

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

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MED X CHANGE, INC CPU DIGITAL RECORDING SYSTEM 1080P; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL Back to Search Results
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.
 
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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 Key6430356
MDR Text Key70900797
Report Number1017294-2017-00029
Device Sequence Number1
Product Code LMB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberDRSHD-1080P
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2017
Initial Date FDA Received03/23/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/06/2017
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 Number1
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