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: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY
  • 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
 

EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY Back to Search Results
Model Number 6290
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 10/14/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
 
Event or Problem Description
Boston scientific received information that the communicator showed a power anomaly.A boston scientific company representative verified that there was a spark on the communicator.The company representative advised the field representative that a new communicator will be sent.The communicator is no longer in service.No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COMMUNICATOR
Common Device Name
ACCESSORY
Manufacturer (Section D)
EXTERNAL MANUFACTURER
MDR Report Key6267079
Report Number2124215-2016-17259
Device Sequence Number844431
Product Code OSR
UDI-Device Identifier00802526570322
UDI-Public(01)00802526570322(11)20150606
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 consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 10/14/2016
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 Number6290
Other Device ID NumberLATITUDE WAVE COMMUNICATOR (MI
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/14/2016
Initial Report FDA Received Date01/20/2017
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
0292; G140; MISMATCH
Patient Age72 YR
-
-