MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for CPU DIGITAL RECORDING SYSTEM 1080P DRSHD-1080P manufactured by Med X Change, Inc.
[72797179]
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.
Patient Sequence No: 1, Text Type: N, H10
[72797180]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2017-00035 |
| MDR Report Key | 6486051 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-03-17 |
| Date Added to Maude | 2017-04-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWIN MARTINEZ |
| Manufacturer Street | 525 8TH ST W |
| Manufacturer City | BRADENTON FL 34205 |
| Manufacturer Country | US |
| Manufacturer Postal | 34205 |
| Manufacturer Phone | 9417949977 |
| 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 | 0 |
| Brand Name | CPU DIGITAL RECORDING SYSTEM 1080P |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2017-04-12 |
| Catalog Number | DRSHD-1080P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-04-12 |