Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. LED HEADLIGHT W/ BATTERIES AND AC/DC POWER SUPPLY - US; LIGHTING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA BURLINGTON, MA, INC. LED HEADLIGHT W/ BATTERIES AND AC/DC POWER SUPPLY - US; LIGHTING Back to Search Results
Catalog Number 90520US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
The customer reported "no light".Burned printed circuit board discovered during dealer inspection.No patient or user issues reported.
 
Manufacturer Narrative
On (b)(6) 2014, integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - the customer's complaint was confirmed.Per the repair evaluation, the control board was faulty and was replaced.Device history evaluation - the product's service history was reviewed.There have been no previous activities performed.Conclusion: unable to determine root cause for this failure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LED HEADLIGHT W/ BATTERIES AND 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 Key4184014
MDR Text Key5026280
Report Number1222895-2014-00029
Device Sequence Number1
Product Code FSR
Combination Product (y/n)N
PMA/PMN Number
K110528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 09/23/2014
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/15/2014
Initial Date FDA Received10/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-