MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. BATTERY CHARGER, SINGLE BAY; LIGHTING

Catalog Number 90523

Device Problems Electrical /Electronic Property Problem (1198); Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• Brand Name: BATTERY CHARGER, SINGLE BAY
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; 22 terry avenue; burlington MA 01803
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: sandra lee ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4905142
• MDR Text Key: 6020031
• Report Number: 1222895-2015-00029
• Device Sequence Number: 0
• Product Code: FSR
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1