MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-08 for BATTERY CHARGER, SINGLE BAY 90523 manufactured by Integra Burlington, Ma, Inc..
[6020031]
Customer initially reports no patient injury. Power supply plugged in and caught fire. On (b)(6) 2015 customer reports "no surgery planned. We just received new power supply (407481) for the battery bay (90523) and manager plugged the power supply into its bay. Plugged into wall and fire caught inside the battery bay. Fire started a second after i plugged it in. " no harm done, no patient involvement. Event took place in clinic department, not in the operation room. 2 of 2 related complaint.
Patient Sequence No: 1, Text Type: D, B5
[14226996]
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
[26114230]
9/9/15 integra investigation completed. Method: failure analysis, device history evaluation failure analysis - the single bay charger was returned, not 60w power supply. Single bay charger power on without a fire or smoke of any kind. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order / manufacturing change order history: none related. Corrective action preventive action history: none related. Health hazard evaluation history: none. Conclusion: it appears the most likely scenario is that the charge controller ic, u4 failed internally, turning q3 on, connecting 24v to q4a drain. Q4a turned on linearly, overheating, which caused a gate to drain short, shorting the 24vdc to ground thru u4-3. Our chargers have been tested to and passed ce level iv esd, 15,000v, on all connectors so eos/esd was not the cause of the failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2015-00029 |
| MDR Report Key | 4905142 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-08 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-06-10 |
| Date Mfgr Received | 2015-09-09 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-07-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA BURLINGTON, MA, INC. |
| Manufacturer Street | 22 TERRY AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BATTERY CHARGER, SINGLE BAY |
| Generic Name | LIGHTING |
| Product Code | FSR |
| Date Received | 2015-07-08 |
| Returned To Mfg | 2015-07-16 |
| Catalog Number | 90523 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON, MA, INC. |
| Manufacturer Address | 22 TERRY AVENUE 22 TERRY AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-08 |