MAUDE Adverse Event Report: MEDTRONIC PHYSIC CONTROL LIFEPAK 12 DEFIBRILLATOR

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2013

Event Type  malfunction  

Event Description

Intra operative pt in v-fib, internal defibrillator paddles opened and pt shocked times 2 with record or abnormal shock on machine.Secondary set of internal paddles obtained and different defibrillator.No harm to pt.Last preventive maintenance completed on defibrillator in (b)(6) 2013.Complete operational check done by facility clinical equipment services staff on the device following abnormal shock reading on (b)(6) 2013.No errors identified in machine operation.

• Brand Name: LIFEPAK 12 DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): MEDTRONIC PHYSIC CONTROL; redmond WA
• MDR Report Key: 3612666
• MDR Text Key: 4172887
• Report Number: MW5034215
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR