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

Catalog Number 90523

Device Problem Sparking (2595)

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

Event Type  malfunction  

Event Description

Customer initially reported sparks noticed when power supply plugged in, (b)(6) 2015 customer reports the sparks came from the charger, no harm done, no further info available.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

• Brand Name: BATTERY CHARGER, SINGLE BAY
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; burlington MA 01803
• Manufacturer Contact: sandre lee ; 315 enterprise drive; 6099366828
• MDR Report Key: 4733241
• MDR Text Key: 5743146
• Report Number: 1222895-2015-00020
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90523
• Device Lot Number: IE122910
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 04/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1