MAUDE Adverse Event Report: COVIDIEN 1710H MEDITRACE 2/PK 20/CA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	40000006
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported, a health care provider attempted to use a defibrillator pad with the wrong automatic external defibrillator (aed) machine and the patient expired as a result.Additionally, the customer stated the issue was user error and not the product.The nurse connected the incorrect defibrillator pad to the defibrillator.The pad was clearly marked on the package and the nurse did not see it.

• Brand Name: 1710H MEDITRACE 2/PK 20/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: 8878277
• Report Number: 9681860-2019-00505
• Device Sequence Number: 18904919
• Product Code: MKJ
• UDI-Device Identifier: 20884527008435
• UDI-Public: 20884527008435
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 40000006
• Device Catalogue Number: 40000006
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death