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); Failure to Read Input Signal (1581)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

A patient arrested 25 minutes after intubation.During the asystole arrest a brief episode of ventricular fibrillation (v-fib) appeared and defibrillator would not charge and removed from the patient care.Advanced cardiac life support (acls) protocol with ongoing chest compressions continued with an automated external defibrillator (aed) used to replace the defibrillator equipment.The rhythm spontaneously converted to a non-shockable rhythm.Patient was pronounced dead and the medical examiner (me) declined the case.Manufacturer response for physiocontrol lp20e defibrillators, physiocontrol (per site reporter).Stryker reps came to the hospital to evaluate and test the machines involved.

• 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: 14436402
• MDR Text Key: 292053179
• Report Number: 14436402
• 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: 04/27/2022,02/18/2022

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: 10220 DA
• Patient Sex: Male
• Patient Weight: 159 KG
• Patient Race: Black Or African American