MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-14 for LED HEADLIGHT ONLY 90500 manufactured by Integra York, Pa Inc..
[67394861]
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
[67394862]
Customer initially reports a short in device and burning smell. On (b)(6) 2017 foot procedure being performed. Customer has no further information.
Patient Sequence No: 1, Text Type: D, B5
[69230867]
On 2/23/17 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation results: failure analysis - functional test found the headlight powered "on" but, the light intensity was not adjustable by the control knob. A burnt, component smell was evident. Inspection of the internal components of the rear module assembly found a burnt component toward the edge of printed circuit board (pcb). The pcb was also, burnt at that location. 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 report was confirmed. The root cause was not conclusively determined. The returned 90500 led headlight was repaired and will be returned to the customer. No manufacturing, workmanship, or material deficiency has been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2017-00015 |
| MDR Report Key | 6329608 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-14 |
| Date of Report | 2017-01-20 |
| Date of Event | 2017-01-16 |
| Date Mfgr Received | 2017-02-23 |
| Date Added to Maude | 2017-02-14 |
| 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 | 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 ONLY |
| Generic Name | LIGHTING |
| Product Code | FSR |
| Date Received | 2017-02-14 |
| Returned To Mfg | 2017-02-06 |
| Catalog Number | 90500 |
| 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 | 2017-02-14 |