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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 6299
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/26/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the product analysis indicates that the allegation was confirmed.The power jack had an anomaly.The electronic component was found to be burned in the power circuitry.
 
Event or Problem Description
Boston scientific received information that the communicator was not powering on.The field representative verified the communicator was not powering up using a new power adapter.The communicator was replaced.The communicator was deactivated.There was no patient involvement.
 
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Brand Name
COMMUNICATOR
Common Device Name
ACCESSORY
Manufacturer (Section D)
EXTERNAL MANUFACTURER
MDR Report Key7658951
Report Number2124215-2018-10544
Device Sequence Number134782
Product Code OSR
UDI-Device Identifier00802526572722
UDI-Public00802526572722
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 06/11/2018
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 Other
Device Model Number6299
Other Device ID NumberLATITUDE CONSULT COMMUNICATOR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/11/2018
Initial Report FDA Received Date07/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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