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U.S. Department of Health and Human Services

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

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STRYKER / PHYSIO-CONTROL, INC LIFEPAK 20E DEFIBRILLATOR/MONITORS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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.
 
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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 Key14436405
MDR Text Key292055003
Report Number14436405
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
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 NumberLIFEPAK 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 FDA04/27/2022
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer05/19/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/19/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age32485 DA
Patient SexMale
Patient RaceWhite
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