MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-23 for CPU DIGITAL RECORDING SYSTEM 1080P DRSHD-1080P manufactured by Med X Change, Inc.
[70900797]
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.
Patient Sequence No: 1, Text Type: N, H10
[70900798]
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.
Patient Sequence No: 1, Text Type: D, B5
[72277341]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2017-00029 |
| MDR Report Key | 6430356 |
| Date Received | 2017-03-23 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-03-04 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BRENDA JOHNSON |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | MED X CHANGE, INC |
| Manufacturer Street | 525 8TH ST W |
| Manufacturer City | BRADENTON FL 34205 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPU DIGITAL RECORDING SYSTEM 1080P |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2017-03-23 |
| Catalog Number | DRSHD-1080P |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MED X CHANGE, INC |
| Manufacturer Address | 525 8TH ST W BRADENTON FL 34205 US 34205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-23 |