MAUDE Adverse Event Report: JOLIFE AB LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS PRODUCT

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 12/12/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control for evaluation.Physio contacted the customer, but they would not provide any additional information, nor was the device returned for evaluation.Physio performed a clinical review on the information that was provided with the following results: a cardiac arrest can be caused by internal bleeding especially if the patient has been exposed to trauma.Both manual and mechanical cpr can cause internal bleeding (see footnotes 1, 2, 3 and 4).The customer would not provide any additional information about the reported event, hence it is not possible to draw any conclusions based on facts.It is not possible to determine if the complications were related to the cardiac arrest, caused by trauma or the provided cpr.With the information provided it cannot be excluded that lucas compressions may have contributed to the reported internal bleeding.Footnote 1: lucas 3, chest compressions system - instructions for use, 100925-01 rev b, valid from co j3022, 2016 jolife ab.Footnote 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.Footnote 3: paradis, n., et al., cardiac arrest, chapter: manual cardiopulmonary techniques.Second edition ed.2007, cambridge: cambridge university press.576-577.Footnote 4: smekal et al, cpr-related injuries after manual or mechanical chest compressions with the lucas tm device: a multi-center study of victims after unsuccessful resuscitation, resuscitation 85 (2014) 1708-1712.(b)(4).

Event Description

It was reported to physio-control that the customer's lucas® 3 chest compression system was used during resuscitation efforts on a patient with anterior stemi and reportedly caused internal bleeding from the lungs which could not be controlled, leading to the patient's death.No patient details or further information were provided.

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; ideon science park; scheelevägen 17; lund 223 7 0; SW 223 70
• Manufacturer (Section G): JOLIFE AB (#3005445717); ideon science park; scheelevägen 17; lund 223 7 0; SW 223 70
• Manufacturer Contact: todd bandy ; 11811 willows rd ne; redmond
• MDR Report Key: 7174420
• MDR Text Key: 96697991
• Report Number: 3015876-2018-00031
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS PRODUCT
• Device Catalogue Number: 99576-000061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/12/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/09/2018
• 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; Life Threatening; Required Intervention