MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFEPAK 20 AND LIFEPAK 20E DEFIBRILLATOR/MONITORS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	70402
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an svt ablation in the ep lab, patient went into ventricular fibrillation.Rn went to charge defibrillator and it would not charge.The defib said "attach pads" but they were already connected to patient.Attending physician started cpr, rn recharged machine and was able to shock patient.Patient came out of vfib and procedure continued.

• Brand Name: LIFEPAK 20 AND LIFEPAK 20E DEFIBRILLATOR/MONITORS
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 12413926
• Report Number: 12413926
• Device Sequence Number: 19716933
• Product Code: MKJ
• UDI-Device Identifier: 00721902439681
• UDI-Public: (01)00721902439681
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/13/2021
• Report Date (Section F): 08/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 70402
• Device Catalogue Number: 70402-000059
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/13/2021