MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-10-16 for LED HEADLIGHT W/ BATTERIES AND AC/DC POWER SUPPLY - US 90520US manufactured by Integra Burlington, Ma, Inc..
[5026280]
The customer reported "no light". Burned printed circuit board discovered during dealer inspection. No patient or user issues reported.
Patient Sequence No: 1, Text Type: D, B5
[12473191]
On (b)(6) 2014, integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the customer's complaint was confirmed. Per the repair evaluation, the control board was faulty and was replaced. Device history evaluation - the product's service history was reviewed. There have been no previous activities performed. Conclusion: unable to determine root cause for this failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2014-00029 |
| MDR Report Key | 4184014 |
| Report Source | 08 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-09-23 |
| Date Mfgr Received | 2014-10-15 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-10-30 |
| 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 AND AC/DC POWER SUPPLY - US |
| Generic Name | LIGHTING |
| Product Code | FSR |
| Date Received | 2014-10-16 |
| Returned To Mfg | 2014-09-30 |
| Catalog Number | 90520US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-10-16 |