MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2017-01-31 for LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AU 90520AU manufactured by Integra York, Pa Inc..
[66217774]
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
[66217775]
The plug that connects at the back of the battery charger is burning up and smoking.
Patient Sequence No: 1, Text Type: D, B5
[69991834]
On 3/2/17 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation. Results: failure analysis - battery charger dual bay faulty. Smoking and sparking at the connector. The device given complete functional check. Recommend replacing the dual bay charger. 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 returned battery charger dual bay was faulty. Smoking and sparking at the connector. The complaint can be confirmed. Charger was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2017-00007 |
| MDR Report Key | 6291659 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-06 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2017-01-31 |
| 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 | DENTAL HYGIENIST |
| 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 | 2017-01-31 |
| Returned To Mfg | 2017-02-09 |
| 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 | 2017-01-31 |