MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 2

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.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.

Event Description

A customer contacted stryker to report that the suction cup of their device tore while being used on the patient.As a result, there is a potential that effective cpr would not be provided, if needed.The patient associated with the reported event did not survive.

Manufacturer Narrative

Stryker performed a clinical review and determined that the device did not contribute to patient outcome.The provider switched to manual cpr immediately according to instruction, it is likely that the interruption in cpr was short, and the incidence did not contribute to the patient¿s outcome.The device was not returned to stryker for evaluation.The reported issue could not be verified or duplicated.The cause of the reported issue could not be determined.

Event Description

A customer contacted stryker to report that the suction cup of their device tore while being used on the patient.As a result, there is a potential that effective cpr would not be provided, if needed.The patient associated with the reported event did not survive.

• Brand Name: LUCAS¿ 2 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17815875
• MDR Text Key: 324212202
• Report Number: 3005445717-2023-00049
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS 2
• Device Catalogue Number: 99576-000024
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2016
• 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): Death
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic