MAUDE Adverse Event Report: MEDTRONIC LIFEPAK 12; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 06/22/2015

Event Type  Injury  

Event Description

Atrial fibrillation (afib) pl1-u4bjy7, pl1-u4h2li, pi1- u5gldj this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LIFEPAK 12
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17528763
• MDR Text Key: 321039414
• Report Number: MW5135692
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: CONMED PADPRO 2001 M-C