MAUDE Adverse Event Report: PHYSIO-CONTROL LIFEPAK 12; DEFIBRILLATOR/ MONITOR

Model Number LIFEPAK 12

Device Problems Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609); Inadequate or Insufficient Training (1643)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762)

Event Date 05/26/2013

Event Type  Injury  

Event Description

Pt was being cardioverted.He was synced and successfully shocked the first 2 times.The third time pt was shocked and went into vfib/torsades.The pt was coded using acls.Pt was revived and stabilized.He was admitted to icu intubated.

• Brand Name: LIFEPAK 12
• Type of Device: DEFIBRILLATOR/ MONITOR
• Manufacturer (Section D): PHYSIO-CONTROL; 11811 willowsrd ne; redmond WA 98052
• MDR Report Key: 4768495
• MDR Text Key: 16460540
• Report Number: 4768495
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LIFEPAK 12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2015
• Distributor Facility Aware Date: 05/26/2013
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Weight: 130