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

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

Patient Problem Internal Organ Perforation (1987)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control for evaluation.There was no report of a device malfunction.Physio performed a clinical review of the information that was reported.This case was firstly suspected as a crime, a suspicion of homicide by smothering which police investigation subsequently did not support.Therefore, the injuries may have been attributed to manual chest compressions during 15 minutes or mechanical cpr during 20 minutes.The cause of death could not be determined, but, the injuries may have been lethal had the patient survived according to the article.Based on the available information, there is no indication of a device malfunction or a use error associated with the reported event.The stabilization strap was reported to have been used.Lucas performs compressions according the guidelines for manual cpr with a depth of 5 cm and a rate of 100-120 compressions per minute.The described complications in this case, are known in the published scientific literature (see footnote 1) except for the extensive intramuscular hemorrhages in posterior neck, between the scapulae and in the lumbar region.Lucas compresses according to the guidelines for manual cpr and in published safety studies lucas has shown to have the same injury profile as manual cpr (see footnote 2).It is not possible to definitively determine if the complications were related to manual or mechanical cpr.However, with the information provided it cannot be excluded that mechanical compressions contributed to the reported injures.As described in the scientific literature, the risk of complications from cpr never outweighs the benefit of return of spontaneous circulation.Knowing the risks is important for treatment issues after rosc, because both manual and mechanical cpr may lead to injuries.Footnote 1.Paradis, n., et al., cardiac arrest, chapter: manual cardiopulmonary techniques.Second edition ed.2007, cambridge: cambridge university press.576-577.Footnote 2. smekal et al, cpr-related injuries after manual or mechanical chest compressions with the lucas device: a multi-center study of victims after unsuccessful resuscitation, resuscitation 85 (2014) 1708-1712.(b)(4).

Event Description

A case was described in literature where a lucas 2 chest compression system had been used on a patient and may have caused life-threatening lesions.It was described that a patient was found unconscious at home.A lay bystander called for help and then provided manual cpr.Approximately 15 minutes later, an ambulance arrived and applied a lucas® 2 chest compression system to the patient.The patient was declared dead after 20 minutes of cpr with the device.  during an autopsy, it was found that the patient had suffered serious injuries; extensive intramuscular hemorrhages in posterior neck, between the scapulae, and in the lumbar region.Investigation of internal organs showed injuries to the lung, spleen, and kidney.The pattern of injury could be attributed to the use of the device.The writers stated that the injuries may have been lethal had the patient survived.

• Brand Name: LUCAS¿ 2 CPR 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, WA ; 4258674000
• MDR Report Key: 6753256
• MDR Text Key: 81362092
• Report Number: 3015876-2017-00932
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/01/2017
• Event Location: Home
• Date Manufacturer Received: 07/01/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 20 YR