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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
Catalog Number 99576-000033
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem Death (1802)
Event Date 08/05/2019
Event Type  Death  
Manufacturer Narrative
(b)(4).Stryker evaluated the customer's device and was unable to duplicate the reported issue.After performing an unrelated repair, proper device operation was observed.The device was subsequently returned to the customer for use.The cause of the reported issue could not be determined.Stryker completed a clinical review and determined that the device use may have contributed to the patient outcome, as the interruption in cpr was one minute.The users did not follow the instructions for use that state if there are interruptions, to remove the device and start manual chest compressions.By following the instructions for use the interruption in cpr is likely to be short, not, as in this case, as long as one minute.
 
Event Description
The customer contacted stryker to report that their device would not work during a patient event.The device indicated the battery was fully charged, however the device did not operate.The device's suction cup was placed on the patient, but the device would not operate when the continuous and 30:2 buttons were pressed.Eventually, the device was removed from the patient and manual cpr was provided.When the device would not operate and it was removed from the patient, it was plugged into the power supply, to charge the battery for 10 minutes.The device subsequently operated correctly.The interruption in cpr was estimated to be approximately 1 minute.It was delayed due to decision making around transporting without a lucas, while it was being charged.The patient did not survive the reported event.
 
Event Description
The customer contacted stryker to report that their device would not work during a patient event.The device indicated the battery was fully charged, however the device did not operate.The device's suction cup was placed on the patient, but the device would not operate when the continuous and 30:2 buttons were pressed.Eventually, the device was removed from the patient and manual cpr was provided.When the device would not operate and it was removed from the patient, it was plugged into the power supply, to charge the battery for 10 minutes.The device subsequently operated correctly.The interruption in cpr was estimated to be approximately 1 minute.It was delayed due to decision making around transporting without a lucas, while it was being charged.The patient did not survive the reported event.
 
Manufacturer Narrative
Section h6, results code of the initial medwatch report indicates no device problem found.Section h6, results code of the initial medwatch report should indicate power source problem identified.Section h6, conclusion code on of the initial medwatch report indicates cause not established.Section h6, conclusion code of the initial medwatch report should indicate shelf life/expiration date exceeded.Section h10 and/or h11 on of the initial medwatch report indicates stryker evaluated the customer's device and was unable to duplicate the reported issue.After performing an unrelated repair,proper device operation was observed.The device was subsequently returned to the customer for use.The cause of the reported issue could not be determined.Stryker completed a clinical review and determined that the device use may have contributed to the patient outcome, as the interruption in cpr was one minute.The users did not follow the instructions for use that state if there are interruptions, to remove the device and start manual chest compressions.By following the instructions for use the interruption in cpr is likely to be short, not, as in this case, as long as one minute.Section h10 and/or h11 of the initial medwatch report should indicate stryker completed a clinical review and determined that the device use may have contributed to the patient outcome, as the interruption in cpr was one minute.The users did not follow the instructions for use that state if there are interruptions, to remove the device and start manual chest compressions.By following the instructions for use the interruption in cpr is likely to be short, not, as in this case, as long as one minute.Stryker evaluated the customer's device and was unable to duplicate the reported issue.After performing an unrelated repair,proper device operation was observed.The device was subsequently returned to the customer for use.It was noted that the batteries used with the device were manufactured in 2015.Stryker recommends that batteries be replaced approximately every two years.The likely cause of the reported issue was determined to be due to the battery.
 
Manufacturer Narrative
It was noted that the batteries used with the device were manufactured in 2015 and should be replaced.Stryker recommends that batteries be replaced approximately every three years.The likely cause of the reported issue was determined to be due to user error, as the customer had not replaced the battery after the recommended 3 year life.
 
Event Description
The customer contacted stryker to report that their device would not work during a patient event.The device indicated the battery was fully charged, however the device did not operate.The device's suction cup was placed on the patient, but the device would not operate when the continuous and 30:2 buttons were pressed.Eventually, the device was removed from the patient and manual cpr was provided.When the device would not operate and it was removed from the patient, it was plugged into the power supply, to charge the battery for 10 minutes.The device subsequently operated correctly.The interruption in cpr was estimated to be approximately 1 minute.It was delayed due to decision making around transporting without a lucas, while it was being charged.The patient did not survive the reported event.
 
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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 Key8951675
MDR Text Key156159190
Report Number0003015876-2019-01456
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,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number99576-000033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2019
Date Manufacturer Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age71 YR
Patient Weight80
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