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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL / PHYSIO-CONTROL INC. STRYKER MEDICAL - LUCAS 2 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL
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STRYKER MEDICAL / PHYSIO-CONTROL INC. STRYKER MEDICAL - LUCAS 2 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Model Number 100582-01
Device Problem Break (1069)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 01/06/2021
Event Type  Death  
Event Description
Lucas device was placed on a patient who was found to be in cardiopulmonary arrest, as indicated by manufacture recommendations and training program.The device malfunctioned after 3-4 minutes of operation.The crew was unable to correct and clear the malfunction on the device until they physically removed the battery from the unit.Mechanical cpr was interrupted during this process, and manual cpr had to be provided.This particular device was recently serviced by stryker medical.Service consisted of replacing a "motherboard" inside of the device.Prior to being placed back into service, the unit was service tested by a stryker service technician and reported to have passed all calibration testing.Fda safety report id # (b)(4).
 
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Brand Name
STRYKER MEDICAL - LUCAS 2 CHEST COMPRESSION SYSTEM
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
STRYKER MEDICAL / PHYSIO-CONTROL INC.
MDR Report Key11147219
MDR Text Key226327456
Report NumberMW5098743
Device Sequence Number1
Product Code DRM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number100582-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
Patient Age71 YR
Patient Weight75
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