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 Myocardial Infarction (1969)

Event Date 01/08/2022

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.Patient fields in which information is not provided were intentionally left blank.Stryker evaluated the customer's device and did not find an issue with it.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.Stryker performed a clinical review of the reported patient event and determine 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 internal thoracic artery.Hemostasis was performed.However, the bleeding did not stop due to the use of an anticoagulant for ecmo treatment.The patient did not survive.The customer advised that the paramedics performed manual chest compressions prior to the patient's arrival at the hospital.

Manufacturer Narrative

Section g3 reportability awareness date of the initial medwatch report (mfr report # 3005445717-2023-00008) indicates: 12/20/2022.Section g3 reportability awareness date of the initial medwatch report (mfr report # 3005445717-2023-00008) should indicate: 01/11/2022.

Event Description

The customer contacted stryker to report that their device caused damage to a patient's internal thoracic artery.Hemostasis was performed.However, the bleeding did not stop due to the use of an anticoagulant for ecmo treatment.The patient did not survive.The customer advised that the paramedics performed manual chest compressions prior to the patient's arrival at the hospital.

• 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: 16163503
• MDR Text Key: 307453827
• Report Number: 3005445717-2023-00008
• 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: 11/20/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death; Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian