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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA BURLINGTON MA, INC. LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US; LIGHTING
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INTEGRA BURLINGTON MA, INC. LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US; LIGHTING Back to Search Results
Catalog Number 90520US
Device Problems Device Emits Odor (1425); Device Inoperable (1663); Failure to Shut Off (2939)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2014
Event Type  malfunction  
Event Description
Customer initially reports fan not working, burnt cable smell and won't turn off.(b)(6) 2014 customer reports the event occurred not long after beginning open heart surgery.Surgeon felt heat from device, there was no harm done.Device was changed out immediately, about 2 minutes delay.
 
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.
 
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Brand Name
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US
Type of Device
LIGHTING
Manufacturer (Section D)
INTEGRA BURLINGTON MA, INC.
burlington MA 01803
Manufacturer Contact
sandra lee
315 enterprise dr.
6099366828
MDR Report Key4171105
MDR Text Key5102139
Report Number1222895-2014-00011
Device Sequence Number1
Product Code FSR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number90520US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2014
Initial Date FDA Received07/15/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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