MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Catalog Number	99576-000044
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E2014029.(b)(4).The device was not returned to physio-control for evaluation.The customer confirmed the stabilization strap were not used, the gel from the patient¿s chest was not removed, and the healthcare providers made an active decision to let compressions continue though there were concerns regarding proper device placement.The instructions for use were not followed that include warnings and cautions for incorrect positioning of the device and inadequate gel removal before usage.Based on the information provided, there was no indication of a device malfunction.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device had potentially caused a liver bleed during a resuscitation.An echo had been performed during the event, for which gel had been applied to the patient's chest.The gel had been left on the patient's chest when the device was applied.No stabilization straps could be deployed, because of other activities.During the use it was observed that the device had to be moved further up the chest to a more superior position on the sternum.Subsequently, the healthcare provider still felt the position wasn't high enough.A decision was then made that it would be detrimental to stop compression.The liver bleed was discovered after the resuscitation and the patient was provided with further treatment.The patient survived the reported event.

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Common Device Name: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• MDR Report Key: 8579682
• Report Number: 0003015876-2019-00778
• Device Sequence Number: 19419718
• Product Code: DRM
• UDI-Device Identifier: 00883873861875
• UDI-Public: 00883873861875
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 99576-000044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 90