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: COVIDIEN UNKNOWN ELECTRODES, LEADWIRES, CABLES; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
  • 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
 

COVIDIEN UNKNOWN ELECTRODES, LEADWIRES, CABLES; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) Back to Search Results
Device Problem Arcing of Electrodes (2289)
Patient Problem Burn(s) (1757)
Event Date 04/25/2019
Event Type  malfunction  
Manufacturer Narrative
Brand name, model number, catalog number, lot number, and unique identifier are unknown but have been requested from the customer.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported the defibrillator pad arced with a visible spark and an audible pop.The staff smelled burning flesh and there was a burn mark under the defibrillator pad.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN ELECTRODES, LEADWIRES, CABLES
Type of Device
PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Manufacturer (Section D)
COVIDIEN
2 ludlow parkway
chicopee MA 01022
Manufacturer (Section G)
COVIDIEN
2 ludlow parkway
chicopee MA 01022
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5084524970
MDR Report Key8670125
MDR Text Key147054876
Report Number1219103-2019-00235
Device Sequence Number1
Product Code DRO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Date Manufacturer Received05/17/2019
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
-
-