MAUDE Adverse Event Report: PHYSIO CONTROL (JOLIFE AB) LUCAS 2; COMPRESSOR, CARDIAC, EXTERNAL

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2014

Event Type  malfunction  

Event Description

The ambulance crew arrived to a call for a cardiac arrest and cardiopulmonary resuscitation (cpr) was in progress by first responders.The emergency medical technician-paramedic (emt-p) applied the lucas 2 cpr device to the patient and initiated.The device showed full battery power, performed compressions for about 20 seconds and alarm/fault light occurred.The device shut off.A restart was attempted and the device alarmed immediately.The device was removed from the patient and cpr continued.(no adverse outcome to patient that was related to device failure.) follow up: the emt-p removed the battery and replaced the battery with a new battery.The device remained inoperable.The device was removed from the ambulance and sent to biomedical engineering.Biomed was unable to reproduce the reported problem condition when testing the device.The unit was ran on a cpr dummy for 15 minutes with straight compressions and 15 minutes on 30:2 compressions with each battery.The device ran fine on both batteries.Shaking of unit and wiggling of batteries did not cause the compression device to fail.No problems found - unable to determine cause of reported problem.

• Brand Name: LUCAS 2
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO CONTROL (JOLIFE AB); 11811 willow rd ne; redmond, WA 98052
• MDR Report Key: 4033880
• MDR Text Key: 4798841
• Report Number: 4033880
• Device Sequence Number: 1
• Product Code: DRM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2014
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 08/25/2014
• Patient Sequence Number: 1