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

Model Number	31469219
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Device Emits Odor (1425); Sparking (2595); Electrical Shorting (2926)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the defibrillation electrodes were connected to a zoll machine for cardioversion.When shock was sent, the connection shorted, sparked, and there was a burning smell.The electrodes did not deliver a shock.There was a delay in care and a minor burn to patient.

• Brand Name: 1410Z KENDALL 1PR/PK 10PR/CA
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 11592845
• Report Number: 9681860-2021-00518
• Device Sequence Number: 4781608
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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
• Device Lot Number: 010464X
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/30/2021
• Patient Sequence Number: 1