MAUDE Adverse Event Report: PHYSIO-CONTROL INC. LIFEPAK 20; DEFRIBRILLATOR, MONITOR, PACER

Model Number LIFEPAK 20

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Death (1802); Septic Shock (2068)

Event Date 04/15/2017

Event Type  Death  

Event Description

During a code blue, the patient was identified to be in ventricular fibrillation (v-fib).The lifepak 20 was charged, and indicated a shock was delivered, but there was no visible twitch exhibited by the patient.The pads were changed and the patient was shocked again, but there was still no visible twitch.The outcome of the code was death, likely related to the severity of septic shock she presented with.The lifepak was removed, and taken to biomed for diagnostics.

• Brand Name: LIFEPAK 20
• Type of Device: DEFRIBRILLATOR, MONITOR, PACER
• Manufacturer (Section D): PHYSIO-CONTROL INC.; 11811 willows rd., n.e.; redmond WA 98052
• MDR Report Key: 6544576
• MDR Text Key: 74427719
• Report Number: 6544576
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: LIFEPAK 20
• Device Catalogue Number: 97402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Weight: 57