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 Problem Perforation (2001)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control for an evaluation since there was no allegation of a product malfunction.  the cause of the reported injury was not conclusively determined; however the reported injury is consistent with injuries that are known to be associated with mechanical chest compressions.In the lucas instruction for use it is written, skin abrasions, bruising and soreness of the chest are common during the use of the lucas chest compression system.Rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.(b)(4).

Event Description

It was reported to physio-control that the use of a lucas 2 chest compression system led to a broken rib which punctured the lung in a patient.No further details about the patient or the event were provided.  physio-control has made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event; however, no response has been received.

• Brand Name: LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; ideon science park scheeleväge; 223 70 lund 223 7 0; SW 223 70
• Manufacturer (Section G): JOLIFE AB #3005445717; scheeleväge 17 ideon science p; lund 223 7 0; SW 223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98073-9706 ; 4258674000
• MDR Report Key: 6823093
• MDR Text Key: 83727184
• Report Number: 3015876-2017-01037
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2017

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: 99576-000024
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/27/2017
• Device Age: 2 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2017
• Date Device Manufactured: 08/12/2015
• 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): Required Intervention