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 Bone Fracture(s) (1870); Pneumothorax (2012)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Based on the available information, there is no indication of a device malfunction or a use error associated with the reported event.(b)(4) continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer reported to (b)(4) that an out-of-hospital patient in cardiac arrest was provided chest compressions by lucas 2 chest compression system (device) for approximately two hours.The cardiac arrest occurred due to hypothermia.The customer reported that, following the use of the device, the patient had severe thoracic trauma with bilateral pneumothorax, pneumomediastinum, left-sided flail chest and right-sided rib fractures.The patient's outcome was not reported.The customer reported that the use of the device may have caused or contributed to the severe thoracic trauma with bilateral pneumothorax, pneumomediastinum, left-sided flail chest and right-sided rib fractures.

Manufacturer Narrative

The customer provided additional information on the event.The patient was a (b)(6) female and did survive the event.The customer has not been able to provide a device serial number.No additional information regarding the device status or evaluation has been provided to physio-control.A conclusive cause of the reported issue could not be determined.

Manufacturer Narrative

The first supplemental medwatch form indicated: the customer provided additional information on the event.The patient was a (b)(6) year old female and did survive the event.The customer has not been able to provide a device serial number.No additional information regarding the device status or evaluation has been provided to physio-control.A conclusive cause of the reported issue could not be determined.Based on the available information, there is no indication of a device malfunction or a use error associated with the reported event.A clinical review of the reported issue was performed by (b)(4) and physio-control with the following feedback/conclusions: with the information provided it is not possible to definitively determine if the injuries were caused by trauma, manual cpr or mechanical cpr.However, with the information provided it is possible that (b)(4) compressions contributed to the thoracic injures with the exception of the pneumo mediastinum.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.Platenkamp et al, complications of mechanical chest compression devices.Neth heart j.2014 sep; 22(9): 404¿407.

• 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: 5525173
• MDR Text Key: 41117882
• Report Number: 3015876-2016-00341
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2016

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 2
• Device Catalogue Number: 3302430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/23/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/25/2016; 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR