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

Catalog Number 3327940-011

Device Problems Failure to Discharge (1169); Defibrillation/Stimulation Problem (1573)

Patient Problem Diminished Pulse Pressure (2606)

Event Date 04/09/2023

Event Type  Death  

Event Description

The patient went into cardiopulmonary arrest on (b)(6) 2023 at approx.19:00.Cpr was initiated and the lifepak 20e defibrillator was attached.He was found to be in pulseless/vf.There was an unforeseeable malfunctioning with the patient's bedside lifepak 20e which resulted in no defibrillation being received.Despite the lifepak 20e appearing functional and showing the dysrhythmia, it did not discharge.Ultimately, patient missed the first two required defibrillations in accordance with acls protocol due to this malfunctioning.A new lifepak 20e was obtained, and patient's first defibrillation was recorded at 19:12.Patient received maximal therapy including multiple defibrillations and other medications.While arranging transfer to icu, patient again went into pulseless vt.Acls protocol was resumed.Family wished to cease resuscitative efforts.Patient death pronounced at 19:43.Manufacture date: 05/11/2017.

• Brand Name: LIFEPAK 20E
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): STRYKER /PHYSIO-CONTROL, INC.
• MDR Report Key: 16817362
• MDR Text Key: 314085627
• Report Number: MW5117050
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3327940-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White