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 Pulmonary Embolism (1498); Hematoma (1884)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4) has investigated the reported issue and concluded that it is unknown, based on the information made available, if the device use has contributed to the injury of the patient as complications involving the liver are known to occur with manual cpr as well as mechanical cpr.In this case it is unclear if the suction cup was placed correctly onto the patient.The lucas device performs compressions according to the aha guidelines for manual cpr with a rate of 100-120 compressions/minute and a depth of 5-6 cm.The suction cup should be placed according to the instruction for use 1.If it is not, it is a high risk of damage to internal organs.The device operating instructions indicate - "if the pressure pad is not in the correct position in relation to the sternum, there is an increased risk of damage to the rib cage and the internal organs.Also, the patient's blood circulation is compromised." there are a number of known complications that could arise following manual external chest compressions as well as with mechanical compressions.Many complications are acceptable only with the knowledge that external chest compressions give a possibility to save life.Ilcor2 stated in 2005 "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the publication by paradis and co-workers3 has summarized studies that evaluated the "other injuries" stated in ilcor and describe damage to organs following external chest compressions as injuries at thorax, abdomen, liver, heart, great vessels.In this summary, it can be concluded that injuries are common during manual cpr.Looking at injuries at the liver about 3% of the manual cpr cases results in liver injuries.1.Http://www.Lucas-cpr.Com/doc_en/100901-00_rev_a_lucas2_ifu_us_lowres.Pdf.2.2005 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations.Part 2: adult basic life support.Resuscitation, 2005.67(2-3): p.187-201.Paradis, n., et al., cardiac arrest, chapter: manual cardiopulmonary techniques.Second edition ed.2007, cambridge: cambridge university press.576-577.(b)(4).

Event Description

A patient was reported as having a liver hematoma and hemoperitoneum following use of the customer's device (mechanical chest compression system).This patient arrived in the adult emergency department in severe respiratory distress.While undergoing investigation for this condition, the patient was intubated and was receiving critical care.He had a period of absent pulses, and underwent cardiopulmonary resuscitation.The customer used their mechanical cpr device to deliver chest compressions.The customer indicated that a massive pe (pulmonary embolism) was later found on a ct scan.Later, surgical service noted significant hemoperitoneum during bedside ex-lap (exploratory laparotomy).It was reported that the surgical service team was concerned that mechanical compression device may have contributed to the patient's liver bleed.The patient did survive the reported event and was discharged from the hospital.

Manufacturer Narrative

Physio-control evaluated the device and was unable to verify any issue with the device.Proper device operation was observed through functional and performance testing.The available event details were evaluated by clinical specialists from jolife and physio-control.It was concluded that it is unknown, based on the information made available, if the device use has contributed to the injury of the patient.In this case it is unclear if the suction cup was placed correctly onto the patient.

Manufacturer Narrative

(b)(4).

• 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 22370 ; SW 22370
• Manufacturer (Section G): JOLIFE AB #3005445717; scheelevägen 17; ideon science park; lund 22370 ; SW 22370
• Manufacturer Contact: jason march ; 11811 willows rd ne; redmond, WA 98052 ; 8004421142
• MDR Report Key: 5316553
• MDR Text Key: 34074457
• Report Number: 3015876-2015-01565
• 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,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• 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: 3302430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/23/2015
• Device Age: 21 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• 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): Life Threatening
• Patient Age: 64 YR
• Patient Weight: 89