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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL LUCAS¿ CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL

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PHYSIO-CONTROL LUCAS¿ CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2018
Event Type  Malfunction  
Event Description

The ambulance crew initiated cardiopulmonary resuscitation for a patient in cardiac arrest. The lucas chest compression system was applied to the patient according to the procedure. A general warning (red alarm triangle) light displayed on the lucas and the lucas did not work. The lucus was promptly removed from the patient and manual cpr was initiated. There was no harm to the patient. The lucus was brought to the biomedical engineering department for inspection. Biomedical engineering reported that they were unable to confirm the reported problem that the unit would not start and the red alarm triangle was illuminated. The device started and performed as intended on numerous tests. Biomed ran in continuous and 30:2 modes until the cooling fan activated. Biomed was unable to reproduce the problem and no problems were found. Lucus was returned to service.

 
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Brand NameLUCAS¿ CHEST COMPRESSION SYSTEM
Type of DeviceCOMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
PHYSIO-CONTROL
11811 willows road ne
redmond WA 98052
MDR Report Key7549954
MDR Text Key109434060
Report Number7549954
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
OTHER Device ID NumberLAST PM WAS 1/18/18
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/15/2018
Device Age6 yr
Event Location Other
Date Report TO Manufacturer05/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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