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

Model Number LUCAS 3

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

Patient Problem Multiple Fractures (4519)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted to correct the incorrect fda registration number that was previously submitted under uf/importer report number # 3005445717-2021-00011.Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.The article from a newspaper, not a scientific journal, are observational comments from the customer and not about a special patient case, therefore it is difficult to make a clinical review from the information received in the article.However, the lucas device has been shown in randomised clinical trial to have the same injury pattern as manual cpr.The customer was contacted multiple times however no serial number was provided and the device was not returned for evaluation.No device malfunction or specific instances of injuries were alleged, only general observation of injuries over time.The root cause of the reported issue could not be determined.

Event Description

Stryker was made aware of the article in kristianstadsbladet, published on 6/22/2021.The article is describing the observations made by the pathologist team regarding the usage of the device on patients.It was observed that the device would potentially cause damage to bones and organs, and cause a greater number of fractures.During autopsies of patients who have died, it was observed that those who received cardiopulmonary resuscitation (cpr) with the device had significantly greater injuries in comparison to manual cpr.

• Brand Name: LUCAS 3 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: 16241326
• MDR Text Key: 308102944
• Report Number: 0003015876-2023-00125
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K062401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2021,01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS 3
• Device Catalogue Number: 99576-000063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2021
• Device Age: 0 YR
• Event Location: Other
• Date Report to Manufacturer: 06/22/2021
• Date Manufacturer Received: 06/22/2021
• 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