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

Model Number LUCAS

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 09/18/2021

Event Type  Death  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with all the available patient information.The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.Stryker performed a clinical review of the reported patient event and determined that with the limited information we have received it cannot be excluded that the damage to the internal thoracic artery was caused by lucas.

Event Description

The customer contacted stryker to report that their device caused damage to a patient's left internal thoracic artery.Surgical treatment was performed to stop the bleeding and to remove the hematoma.The patient did not survive.

Manufacturer Narrative

Section g3 reportability awareness date of the initial medwatch report (mfr report # 3005445717-2023-00007) indicates: 12/20/2022.Section g3 reportability awareness date of the initial medwatch report (mfr report # 3005445717-2023-00007) should indicate: 10/26/2021.

Event Description

The customer contacted stryker to report that their device caused damage to a patient's left internal thoracic artery.Surgical treatment was performed to stop the bleeding and to remove the hematoma.The patient did not survive.

• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16163498
• MDR Text Key: 307455023
• Report Number: 3005445717-2023-00007
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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: 99576-000067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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; Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian