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

Model Number LUCAS

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

Patient Problem Cardiac Arrest (1762)

Event Date 02/08/2023

Event Type  Injury  

Event Description

Stryker came to aware from an article from the american journal of case report of a report that a lucas device had potentially caused liver lacerations during patient use.

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Stryker performed a clinical review regarding the reported issue.There is insufficient reported information to determine the device's contribution to the reported outcome.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Manufacturer Narrative

The device was not returned to stryker for evaluation.Stryker has made multiple attempts to contact the customer for more information, but no response has been received from the customer.The cause of the reported issue could not be determined.H3 other text: device not return.

Event Description

Stryker came to aware from an article from the american journal of case report of a report that a lucas device had potentially caused liver lacerations during patient use.

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL / DRM
• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17625259
• MDR Text Key: 321973417
• Report Number: 3005445717-2023-00048
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K062401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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