MAUDE Adverse Event Report: JOLIFE AB LUCAS 2; LUCAS 2 CHEST COMPRESSION SYSTEM

Model Number LUCAS 2

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Full thickness (Third Degree) Burn (2696)

Event Date 01/09/2019

Event Type  Injury  

Event Description

This (b)(6) y/o obese female with a bmi of 49.4 was brought into the ed in cardiac arrest due to severe hypothermia and was subsequently found to have 3rd degrees burns with 2% to her total body surface area (tbsa) secondary to prolonged mechanical chest compressions via the lucas 2 chest compression system.On (b)(6) 2019 this (b)(6) y/o female with pmh of ovarian cancer and chronic back pain bib ems after being found in her driveway, cold with wet clothes and confused.According to neighbor, pt had been laying there since the night prior.On route to hosp, pt had v-fib arrest x 2 with cpr given in between.Intubated on the field.Pt received a total of 5 shocks according to ems.Temp on arrival to ed reported as 74 degrees.In ed, pt continued to have v fib arrest and treated per acls protocol, received multiple shocks, multiple rounds of epinephrine, calcium gluconate, amiodarone, sodium bicarb and fluids and subsequently admitted to micu.On (b)(6) 2019 lucas device in place from 0807 to 1120.Temperature on arrival 74 degrees f.Pt survived and was discharged to sub acute rehab on (b)(6) 2019.

• Brand Name: LUCAS 2
• Type of Device: LUCAS 2 CHEST COMPRESSION SYSTEM
• Manufacturer (Section D): JOLIFE AB; scheelevagen 17
• MDR Report Key: 8549706
• MDR Text Key: 143074390
• Report Number: 8549706
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS 2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 127