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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COGENTIX MEDICAL, INC. BLS-1000 PORTABLE LED LIGHT SOURCE
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COGENTIX MEDICAL, INC. BLS-1000 PORTABLE LED LIGHT SOURCE Back to Search Results
Catalog Number 07-3048
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
While there was no adverse impact to the user or patient due to the overheating and fire of the battery charger, cogentix medical is reporting this incident as were it to recur, there is possibility of harm.The user's manual for the led light source has a specific warning which states to not attempt to recharge non-rechargable batteries as it may cause fire or explosion.Additionally, due to the user error, in response to this incident, cogentix medical has removed all reusable batteries from this clinic and is only supplying disposable batteries so the battery charger will not need to be used in the future.
 
Event Description
The battery charger which is used with the bls-1000 led light source caught fire after a clinic accidentally mixed a reusable battery in with the disposable battery.This resulted in the batteries and charger overheating and caused minor damage to the wall where the charger was located as well as a box located next to it.There was no impact to the patient or user due to this fire.
 
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Brand Name
BLS-1000 PORTABLE LED LIGHT SOURCE
Type of Device
LED LIGHT SOURCE
Manufacturer (Section D)
COGENTIX MEDICAL, INC.
40 ramland road south
orangeburg NY 10962
Manufacturer Contact
nicole boser
40 ramland road south
orangeburg, NY 10962
9524266141
MDR Report Key10879799
MDR Text Key218516920
Report Number2242464-2020-00001
Device Sequence Number1
Product Code NTN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/20/2020
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 Number07-3048
Initial Date Manufacturer Received 11/12/2020
Initial Date FDA Received11/20/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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