MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-05-20 for LITHIUM ION BATTERIES - QTY 2 90522 manufactured by Integra York, Pa Inc..
[45587210]
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
[45587211]
Customer initially reports that the battery was getting hot inside holster on surgeons hip. On (b)(6) 2016 customer reports that doctor was performing a spinal fusion when he felt the battery was hot, after one hour of use.. Battery was removed from holster. The heat burned a hole in the battery. No harm to the doctor. #1 of 2 related complaints.
Patient Sequence No: 1, Text Type: D, B5
[47926266]
On 6/7/2016 integra investigation completed. Manufacture date unknown method: failure analysis, device history evaluation, results: failure analysis - battery only received. Inserted battery into holster, connected to led headlight for 2 hours on highest setting. Run time temp was 81. 9f, which is not an abnormal temperature for a battery in use. Battery tests within specification. Complaint report is unconfirmed. 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 report of battery getting hot inside holster could not be confirmed. After the evaluation of the returned sample, it was found that the battery could power a headlight and not over-heat in holster. The complaint report is unconfirmed; testing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00070 |
| MDR Report Key | 5669471 |
| Report Source | USER FACILITY |
| Date Received | 2016-05-20 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-05-04 |
| Date Mfgr Received | 2016-06-07 |
| Date Added to Maude | 2016-05-20 |
| 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 | LITHIUM ION BATTERIES - QTY 2 |
| Generic Name | LIGHTING |
| Product Code | FSR |
| Date Received | 2016-05-20 |
| Returned To Mfg | 2016-05-19 |
| Catalog Number | 90522 |
| 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 | 2016-05-20 |