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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN, INC. 3.5V RECHAREABLE HANDLE
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WELCH ALLYN, INC. 3.5V RECHAREABLE HANDLE Back to Search Results
Model Number 71000-A
Device Problem Fire (1245)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2014
Event Type  malfunction  
Event Description
The customer alleged that there was an electrical failure involving a welch allyn rechargable handle that caused her electrical receptacle to catch fire.The other outlet of the receptacle had a weight scale plugged into it.The actual cause of the fire cannot be determined at this time.We are filling this report in an abundance of caution until further investigation can be conducted.
 
Manufacturer Narrative
Welch allyn is reporting this event in an abundance of caution as it is unclear which device or component caused the problem.The device evaluation is not yet complete.A follow up report will be submitted when the evaluation is complete.
 
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Brand Name
3.5V RECHAREABLE HANDLE
Type of Device
NA
Manufacturer (Section D)
WELCH ALLYN, INC.
4341 state st. rd.
skaneateles falls NY 13153
Manufacturer Contact
pearley bhambri, director
4341 state st. rd.
p.o. box 220
skaneateles falls, NY 13153-0220
3156852568
MDR Report Key3606090
MDR Text Key4094332
Report Number1316463-2014-00001
Device Sequence Number1
Product Code FCO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71000-A
Device Catalogue Number71000-A
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/22/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2014
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 Reuse
Patient Sequence Number1
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