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

Catalog Number 99576-000026

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

Patient Problem Hyperemia (1904)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A clinical review of the reported event was performed by clinical specialists from (b)(4) and physio-control with the following observations and conclusions: the reported internal bleeding from the swollen liver could be caused by cpr.Liver rupture is a known complication of chest compression for manual cpr (reference 1) as well as for mechanical cpr (reference 2).The reported incidence rate of liver injury from manual cpr it is about 3% (reference 1).In this incident there is no information about the placement of the suction cup.The stabilization strap, which prevent the device from sliding downwards, was not used.This is not according to the instruction for use, which provides the following warnings and recommendation for use (reference 3)."warning - changed position during operation if the position of the suction cup changes during operation or during defibrillation, immediately push adjust and adjust the position.Always use the lucas stabilization strap to help secure the correct position." based on the limited information provided by the customer the liver injury may have been related to manual cpr or mechanical cpr.The stabilization strap was not used, but could probably have prevented any device change in positioning.Therefore it may not be excluded that manual or mechanical cpr contributed to the liver injury, however the patient died from brain edema and not from the liver injury.This was confirmed by the customer.A physio-control service representative evaluated the device.Proper device operation was confirmed through functional and performance testing.The device was subsequently returned to the customer.References; cardiac arrest, the science and practice of resuscitation medicine.Paradis, halperin page 576 de rooij pp., et al., fatal complication secondary to mechanical chest compression device.Resuscitation.2009.80: p.12141215.Http://www.Lucas-cpr.Com/doc_en/100901-00_rev_a_lucas2_ifu_us_lowres.Pdf.

Event Description

It was reported to physio-control that the customer used their lucas 2 chest compression system on a female patient in cardiac arrest.After both manual and mechanical cpr had been provided, severe internal bleeding in the patient's liver was observed.It could not be determined whether the damage was caused by manual or mechanical chest compressions.The patient expired.The customer reported that the patient's outcome was not a result of any injury that may have been caused by either manual or mechanical chest compressions.According information provided by the customer, the patient died as a result of brain edema.There was no report of a device malfunction.

• 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; scheelevägen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: yuchol kim ; 11811 willows road ne - po box; redmond, WA 98073-9706 ; 4258674000
• MDR Report Key: 6098223
• MDR Text Key: 59715039
• Report Number: 3015876-2016-01366
• 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: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 99576-000026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/14/2016
• Device Age: 5 YR
• Event Location: Hospital
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2011
• 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