MAUDE Adverse Event Report: SUMMIT SQUARE SHOPPING CENTER #402 MEDTRONIC; LIFEPAK 12

Model Number LP 12

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/10/2016

Event Type  Death  

Event Description

During the course of treatment of a patient in cardiac arrest, the monitor/defibrillator failed to deliver 2 defibrillations.The lp12 was charged to 360j and prior to the health professional being able to deliver the shock the device cancelled or "dumped" the charge.This occurred twice before the device was replaced.

• Brand Name: MEDTRONIC
• Type of Device: LIFEPAK 12
• Manufacturer (Section D): SUMMIT SQUARE SHOPPING CENTER #402; langhorne PA 19047
• MDR Report Key: 5883664
• MDR Text Key: 52410750
• Report Number: 5883664
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2016

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
• Device Operator: Health Professional
• Device Model Number: LP 12
• Other Device ID Number: VLP12-02-005985
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2016
• Distributor Facility Aware Date: 08/10/2016
• Device Age: 10 YR
• Event Location: Other
• Date Report to Manufacturer: 08/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2016
• 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): Death
• Patient Age: 78 YR