MAUDE Adverse Event Report: JOLIFE AB LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Date 08/05/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

It was reported to physio-control that the use of a lucas® 2 chest compression system led to a punctured aorta in a patient.The punctured aorta was discovered post mortem by the county coroner.The coroner reported that the patient had not experienced any kind of trauma (prior to the use of the lucas device) which would have caused a punctured aorta.The patient did not survive the event.No further details about the patient or the event were provided.The date of the patient death was not reported.

Manufacturer Narrative

 the customer was unable to identify which of their device's had been used in the reported event; therefore, the customer decided to return all three (3) of their devices for evaluation.Physio-control evaluated all 3 (three) of the customer's devices (serial numbers (b)(4)).Proper device operation was observed through functional and performance testing. the devices were then returned to the customer for use.The cause of the reported injuries was not conclusively determined, however the reported injuries are consistent with injuries that are known to be associated with both manual and mechanical chest compressions.

• Brand Name: LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; scheelevägen 17; ideon science park; lund SE 22 3 70; SW SE 223 70
• Manufacturer (Section G): JOLIFE AB #3005445717; scheelevägen 17; ideon science park; lund SE 22 3 70; SW SE 223 70
• Manufacturer Contact: yuchol kim ; 11811 willows road ne; redmond, WA 98073-9706 ; 4258674000
• MDR Report Key: 5926610
• MDR Text Key: 53865380
• Report Number: 3015876-2016-01038
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS 2
• Device Catalogue Number: 99576-000024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/05/2016
• Event Location: Ambulatory Health Care Facility
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death