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

Model Number LIFEPAK 20E

Device Problems Failure to Charge (1085); Defibrillation/Stimulation Problem (1573)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

A patient had cardiac arrest after arrival in the intensive care unit (icu) and advanced cardiac life support (acls) protocol was initiated.Defibrillator pads were applied for ventricular fibrillation and the message pop-up stated, "attach electrodes".The team assessed the machine by disconnecting, unhooking, turning the machine on and off.The machine was heard charging, but the machine would not discharge.The automated external defibrillator (aed) was used to deliver the shocks as indicated with ongoing cardiopulmonary resuscitation.Resuscitation was unsuccessful.Manufacturer response for physio control lp20e defibrillators, "physio control" (per site reporter).Stryker reps came to the hospital to evaluate and test the machines.

• Brand Name: LIFEPAK 20E DEFIBRILLATOR/MONITORS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): STRYKER / PHYSIO-CONTROL, INC; 11811 willows rd ne; redmond WA 98052
• MDR Report Key: 14436405
• MDR Text Key: 292055003
• Report Number: 14436405
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 04/27/2022,03/15/2022

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
• Device Operator: Health Professional
• Device Model Number: LIFEPAK 20E
• 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: 04/27/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Male
• Patient Race: White