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 Tissue Damage (2104)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A physio-control clinical specialist reviewed the reported information with the following observations and conclusion: the soft tissue injury on the chest is likely caused by the mechanical compressions from lucas during 25 minutes.This is one of the potential side effects per the instructions for use(1); the international liaison committee on resuscitation (ilcor) recognizes the following side effects of cpr: "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.After resuscitation, all patients should be reassessed and re-evaluated for resuscitation-related injuries." apart from the above, bruising and soreness of the chest are common during use of the lucas chest compression system.In this case the customer reported the stabilization straps were not used and the device was placed low, deeper on the chest due to the broken sternum and tilted to the right.The instructions for use provide the following contraindication and warning: contraindications do not use the lucas chest compression system in these cases: if it is not possible to position lucas safely or correctly on the patient's chest.Warning - incorrect position over chest.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.Ref; http://www.Lucas-cpr.Com/doc_en/100666-01_rev_a_lucas2_ifu_gb_web2.Pdf physio 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

It was reported to physio-control that, following the use of a lucas 2 chest compression system, the patient exhibited significant soft tissue damage under the device suction cup and other thorax injuries.When paramedics arrived, the patient (a (b)(6) male) was found lying on the floor (indoors) with an unknown downtime.Manual cpr was provided for approximately 15 minutes.The patient's sternum broke during manual cpr.The paramedics then placed the lucas device on the patient whose chest had collapsed due to the broken sternum.When the device was placed on the patient's chest, it slightly tilted to the right side.No stabilization straps were used and the patient was not moved from his position on the floor.Mechanical cpr was provided for approximately 25 minutes with the lucas device.When the lucas device was removed from the patient, it was discovered that the patient had received significant soft tissue damage under the device suction cup and additional thorax injuries.

Manufacturer Narrative

Physio-control evaluated the device and proper device operation was confirmed during functional and performance testing.The reported issue regarding device alarms was not duplicated.The cause of the reported issue regarding device alarms was not determined.There were no issues observed with the device related to the patient's skin damage.A damaged hood communication ribbon cable was replaced.The device was subsequently returned to the customer for use.(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 SE 22 3 70; SW SE 223 70
• Manufacturer (Section G): JOLIFE AB #3005445717; scheelevägen 17; ideon science park; lund 223 7 0; SW 223 70
• Manufacturer Contact: jason march ; 11811 willows road ne; redmond, WA 98052 ; 8004421142
• MDR Report Key: 5621383
• MDR Text Key: 44120104
• Report Number: 3015876-2016-00496
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 04/28/2016

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2013
• 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
• Patient Age: 92 YR