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

Model Number 70402

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Ventricular Fibrillation (2130)

Event Date 08/12/2021

Event Type  malfunction  

Event 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
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 12413926
• MDR Text Key: 269586684
• Report Number: 12413926
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00721902439681
• UDI-Public: (01)00721902439681
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70402
• Device Catalogue Number: 70402-000059
• 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: 08/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA