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

Model Number LUCAS

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

Patient Problem Pain (1994)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr # 0003015876-2020-00532.Physio-control performed a clinical review of the reported event and determined that user error contributed to the serious injury of the patient.The patient had his arm strapped to the device with the patient straps during the prolonged resuscitation.This resulted in compartment syndrome to the patient's left hand.

Event Description

Physio-control was made aware of the article "compartment syndrome of the hand as a complication of prolonged mechanical cardiopulmonary resuscitation" published in anaesthesia reports 2020-8, that mentioned a patient event where the device use had potentially caused compartment syndrome in a 45-year-old male patient during mechanical cardiopulmonary resuscitation.Cardiopulmonary resuscitation along with aggressive rewarming achieved return of spontaneous circulation.Despite preservation of neurological function the patient died of complications from the cardiac arrest after an extended intensive care unit stay.

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16224424
• MDR Text Key: 307904649
• Report Number: 3005445717-2023-00023
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: UNK_SMP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Other