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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC./PHYSIO-CONTROL MANUFACTURING, INC. LUCAS II; COMPRESSOR, CARDIAC, EXTERNAL
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PHYSIO-CONTROL, INC./PHYSIO-CONTROL MANUFACTURING, INC. LUCAS II; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Model Number LUCAS 2
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Reset Problem (3019)
Patient Problem Fall (1848)
Event Date 08/06/2016
Event Type  malfunction  
Event Description
We were called for the man down in the bathroom.When we arrived, the fire department had the patient out of the bathroom doing cpr no shock advised.My partner and i set up the lucus2 device to start mechanical cpr.When we turned it on, the lucus 2 started to beep and red flashing lights went off.I quickly tried to reset the lucus 2 by turning it off and taking the battery out.I placed battery back in place and turned the lucus2 on.We had the same result.Manual cpr started again.
 
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Brand Name
LUCAS II
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
PHYSIO-CONTROL, INC./PHYSIO-CONTROL MANUFACTURING, INC.
11811 willows rd ne
redmond WA 98052
MDR Report Key5959593
MDR Text Key55052912
Report Number5959593
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 Other
Type of Report Initial
Report Date 08/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2016
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberLUCAS 2
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2016
Event Location Other
Date Report to Manufacturer08/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS; PT IN CARDIAC ARREST AT HOME FROM OPIOD OVERDOSE,
Patient Age44 YR
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