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

Model Number LP20E

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Loss of consciousness (2418)

Event Date 09/05/2022

Event Type  Death  

Event Description

During cardiac arrest, defibrillator did not deliver a shock as expected.Staff had stopped cpr ready to shock initially and the defibrillator made the expected noise as it was cycling and then stopped.Cpr restarted.Provider took over and switched the defibrillator to manual and again stopped cpr and initiated shock with same results.He checked all cables, connections and pushed the left side cable into the front of the machine and the shock was successful on the third try.Pt was not connected to the defib ekg cables.Pt was subsequently shocked two more times (with immediate return of cpr compression and ventilation in interim), all with provider pushing in on the left side cable.All attempts at resuscitation were unsuccessful.Patient arrived at ed at 02:50.Pt unresponsive at 03:07.First shock of 200 joules successfully delivered at 03:11.Second shock of 200 joules at 03:12.Final shock of 300 joules at 03:15.Cpr continued until 03:30.Patient expired.Fda safety report id# (b)(4).

• Brand Name: PHYSIO-CONTROL LIFEPAK DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE
• Manufacturer (Section D): STRYKER PHYSIO-CONTROL, INC.
• MDR Report Key: 15462214
• MDR Text Key: 300354994
• Report Number: MW5112153
• 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: 09/16/2022

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: LP20E
• Device Lot Number: CONTROL #1077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 123 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White