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 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 05/19/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the product analysis confirmed the allegation against the power adapter.The product performance engineers found out that the power adapter had a missing blade adapter plate and was melted.The communicator was able to pass all baseline tests after a working power adapter was used.
 
Event or Problem Description
Boston scientific received information that the communicator had no power as the power cord was burned up.The company representative sent a return label to the patient and ordered a new communicator.The communicator is out of 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 Key6680647
Report Number2124215-2017-10493
Device Sequence Number1063308
Product Code OSR
UDI-Device Identifier00802526570209
UDI-Public(01)00802526570209(11)20150211
Combination Product (Y/N)N
Initial Reporter StateMO
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) 05/19/2017
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 Manufacturer06/13/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/19/2017
Initial Report FDA Received Date06/30/2017
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
0293; E160
Patient Age56 YR
-
-