MAUDE Adverse Event Report: COVDIEN 1410Z KENDALL 1PR/PK 10PR/CA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	31469219
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: during a cardioversion procedure on a patient, nursing staff noticed that fumes were emanating from the pads.Other issues with the pads are the smell of fumes during cardioversions, popping sound and arching coming from machine, wires burning and the electrode pads do not adhere well.

• Brand Name: 1410Z KENDALL 1PR/PK 10PR/CA
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): COVDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 10546611
• Report Number: 9681860-2020-00514
• Device Sequence Number: 11521370
• Product Code: MKJ
• UDI-Device Identifier: 20884527010315
• UDI-Public: 20884527010315
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: No Information
• Device Model Number: 31469219
• Device Catalogue Number: 31469219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1