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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL
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PHYSIO-CONTROL, INC. - 3015876 LUCAS 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Model Number LUCAS
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customers device and was unable to duplicate the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.A clinical review was performed and concluded that the interruption in cpr might have been too long due to non-compliance to the instruction for use, the rescuer should have started manual cpr directly according to the instruction for use.Use of the lucas device may have contributed to the patient¿s outcome.
 
Event Description
The customer contacted physio-control to report that their device blocked during patient use.The users tried to restart the device, but it did not resolve the issue.Subsequently, manual cpr was provided, but it was reported that the reported issue delayed the treatment of the patient.The patient passed away a few days after the event at the intensive care unit.
 
Event Description
The customer contacted physio-control to report that their device blocked during patient use.The users tried to restart the device, but it did not resolve the issue.Subsequently, manual cpr was provided, but it was reported that the reported issue delayed the treatment of the patient.The patient passed away a few days after the event at the intensive care unit.
 
Manufacturer Narrative
H1 of the initial submission indicated the type of reportable event is death.H1 of the initial submission should indicate the type of reportable event is malfunction.B1 of the initial submission indicated adverse event and product problem b1 of the initial submission should indicate product problem b2 of the initial submission indicated death b2 of the initial submission should indicate blank h6 of the initial submission indicated the patient code is death.H6 of the initial submission should indicate the patient code is no consequences or impact to patient.A clinical review was performed and it was determined that a use error occurred due to the customer delay in providing manual cpr.This error likely caused the adverse event.The reported malfunction does not inhibit the customer from providing manual cpr immediately in conjunction with the instructions for use.Manual cpr is equivalent to lucas compressions and therefore the lucas device report of blocking (stopping) twice during heart compressions did not contribute to the patient outcome.Physio-control evaluated the customers device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
 
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Brand Name
LUCAS 2 CPR CHEST COMPRESSION SYSTEM
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
ideon science park
redmond WA 98052
MDR Report Key9539360
MDR Text Key173354957
Report Number0003015876-2020-00013
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
PMA/PMN Number
K090422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLUCAS
Device Catalogue Number99576-000025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Date Manufacturer Received05/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age46 YR
Patient Weight60
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