MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-09 for LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AU 90520AU manufactured by Integra York, Pa Inc..
[45001842]
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
[45001843]
No light output. Burning smell from headlight pcb (printed circuit board). There was no delay to surgery and no medical intervention was required. No patient injury or harm. No adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
[47922909]
On 6/17/2016 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation. Results: failure analysis - (b)(4) service centre. Evaluation summary: the reported complaint could not be replicated in service centre, after over 10 hours operation. Light output is acceptable, and burning smell is not evident. Internally no components are damaged. Conclusion: unconfirmed complaint; could not be duplicated. Evaluation in billerica repair depot: a visual inspection found no visible, physical damage. Inspection of the printed circuit board in the rear module assembly also, found no visible damage or burnt or broken components. The led headlight was functionally tested an additional 30 minutes. There was no burning smell and the unit functioned as intended. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order / manufacturing change order history: none. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: the complaint was unconfirmed, unit was operated over 10 hours with no evidence of a burning smell. Internal components also revealed no evidence of burning or overheating.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00064 |
| MDR Report Key | 5640733 |
| Date Received | 2016-05-09 |
| Date of Report | 2016-04-18 |
| Date of Event | 2016-04-12 |
| Date Mfgr Received | 2016-06-17 |
| Date Added to Maude | 2016-05-09 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AU |
| Generic Name | LIGHTING |
| Product Code | FSR |
| Date Received | 2016-05-09 |
| Returned To Mfg | 2016-05-27 |
| Catalog Number | 90520AU |
| 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 YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-09 |