MAUDE Adverse Event Report: MEDTRONIC/PHYSIOCONTROL LIFEPAK 20 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number LIFEPAK 20

Device Problem Charging Problem (2892)

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130); Complete Heart Block (2627)

Event Date 05/02/2018

Event Type  Injury  

Event Description

The pt was identified to have gone into ventricular fibrillation and the nurse immediately went into the room and initiated.Cpr as the code team responded.The patches were placed on the pt and the defibrillator was changed to the appropriate joules but when the shock button was push, the charge was dropped.The staff immediately charged it again and delivered the shock,converting the rhythm to bradycardia with a high degree heart block.When attempting to pace the pacer shut off having to initiate the pacer button.The pt soon lost pulse again and attempts at resuscitation ceased after 36 min of cpr.The biomed dept tested the defibrillator with the paddles and therapy cable and it worked correctly and passed the pm procedure.

• Brand Name: LIFEPAK 20 DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): MEDTRONIC/PHYSIOCONTROL; redmond WA 98052
• MDR Report Key: 7533672
• MDR Text Key: 109101053
• Report Number: MW5077352
• Device Sequence Number: 0
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIFEPAK 20
• Device Catalogue Number: 3202487-015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 97