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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY
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EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY Back to Search Results
Model Number 6280
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/30/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory and the power brick head was burned.A new power brick was used and the communicator was able to pass all the baseline tests.The communicator was deactivated.
 
Event or Problem Description
Boston scientific received information that the power cord was melted.A boston scientific company representative verified that the power cord and the communicator will be returned for analysis.The communicator was deactivated.No adverse patient effects were reported.
 
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Brand Name
COMMUNICATOR
Common Device Name
ACCESSORY
Manufacturer (Section D)
EXTERNAL MANUFACTURER
MDR Report Key6283354
Report Number2124215-2017-01063
Device Sequence Number637911
Product Code OSR
UDI-Device Identifier00802526570209
UDI-Public(01)00802526570209(11)20150302
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 11/30/2016
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
Operator of Device Lay User/Patient
Device Model Number6280
Other Device ID NumberLATITUDE WAVE COMMUNICATOR (IS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/30/2016
Initial Report FDA Received Date01/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
4087; 4088; K173
Patient Age44 YR
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