MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-15 for LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US 90520US manufactured by Integra Burlington Ma, Inc..
[5102139]
Customer initially reports fan not working, burnt cable smell and won't turn off. (b)(6) 2014 customer reports the event occurred not long after beginning open heart surgery. Surgeon felt heat from device, there was no harm done. Device was changed out immediately, about 2 minutes delay.
Patient Sequence No: 1, Text Type: D, B5
[12416269]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2014-00011 |
| MDR Report Key | 4171105 |
| Report Source | 06 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-06-16 |
| Date Mfgr Received | 2014-06-23 |
| Date Added to Maude | 2014-10-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US |
| Generic Name | LIGHTING |
| Product Code | FSR |
| Date Received | 2014-07-15 |
| Catalog Number | 90520US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON MA, INC. |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-15 |