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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOLIFE AB/ PHYSIO-CONTROL LUCAS CHEST COMPRESSION DEVICE; COMPRESSOR, CARDIAC, EXTERNAL
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JOLIFE AB/ PHYSIO-CONTROL LUCAS CHEST COMPRESSION DEVICE; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 07/03/2017
Event Type  malfunction  
Event Description
The patient arrived at the er complaining of severe chest pain for over 2 hours.While being prepared for the chest pain protocol minutes after his arrival he went into full cardiopulmonary arrest.Because it was a witnessed arrest, a lucas chest compression device was used to enhance the chances of survival.The lucas chest compression device is designed to operate with the battery charger plugged into ac outlet.Very shortly after the device was plugged in, a burnt plastic smell was observed to be coming from the charging device.It was quickly unplugged and moved to a safe area.The lucas chest compression device continued to operate normally during the length of the code, approximately 1.5 hours.
 
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Brand Name
LUCAS CHEST COMPRESSION DEVICE
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
JOLIFE AB/ PHYSIO-CONTROL
lund, se
MDR Report Key6714015
MDR Text Key80170653
Report NumberMW5070991
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
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 07/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2017
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 Age85 YR
Patient Weight68
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