MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

Device Problem Unexpected Shutdown (4019)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Physio-control evaluated the customer's device and found that two of their three batteries would not hold a charge and that the charge port was damaged and would not hold the charging cord in place.Physio replaced the dc input port to resolve the reported issue.The customer will also be provided with replacement batteries.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device unexpectedly shut off while in use with a patient.Manual cpr was then delivered.The patient later died at the hospital.Multiple attempts to obtain patient information from the customer were made without response.A clinical review determined that the device malfunction may have contributed to the patient's death.

Manufacturer Narrative

Section h1 of the initial medwatch report indicates: type of reportable event is serious injury.Section h1 of the initial medwatch report should indicate: type of reportable event is death.Physio-control evaluated the customer's device and verified the reported issue.Physio found the charge port was damaged and, as a result, the batteries would not hold a charge.Physio replaced the damaged power inlet and replaced the batteries to resolve the issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The root cause was determined to be the batteries and power inlet.Physio performed a clinical review that determined that the user had not followed the instructions for use; therefore, it is likely that the interruption in cpr was longer compared to if they had followed the instruction for use.

Event Description

The customer contacted physio-control to report that their device unexpectedly shut off while in use with a patient.Manual cpr was then delivered.The patient later died at the hospital.Multiple attempts to obtain patient information from the customer were made without response.A clinical review determined that the device malfunction may have contributed to the patient's death.

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.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.

Event Description

The customer contacted physio-control to report that their device unexpectedly shut off while in use with a patient.Manual cpr was then delivered.The patient later died at the hospital.Multiple attempts to obtain patient information from the customer were made without response.A clinical review determined that the device malfunction may have contributed to the patient's death.

• Brand Name: LUCAS CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• MDR Report Key: 9980147
• MDR Text Key: 188339953
• Report Number: 0003015876-2020-00538
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death