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

Model Number LUCAS

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 08/04/2022

Event Type  Death  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.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.Stryker performed a clinical review regarding the reported issue.There is insufficient reported information to determine the device's contribution to the reported outcome.

Event Description

The customer contacted stryker to report that their device caused bilateral thoracic artery injury after use.The patient involved in the reported event did not survive.

Manufacturer Narrative

Stryker evaluated the customer¿s device and was unable to verify or duplicate the reported issue.The device passed functional and performance testing and was returned to the customer for use.The cause of the reported issue could not be determined.

Event Description

The customer contacted stryker to report that their device caused bilateral thoracic artery injury after use.The patient involved in the reported event did not survive.

Manufacturer Narrative

Section g3 reportability awareness date of the initial medwatch report (mfr report #3005445717-2023-00006) indicates: 12/20/2022.Section g3 reportability awareness date of the initial medwatch report (mfr report #3005445717-2023-00006) should indicate: 11/15/2022.

Event Description

The customer contacted stryker to report that their device caused bilateral thoracic artery injury after use.The patient involved in the reported event did not survive.

• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16164628
• MDR Text Key: 307455889
• Report Number: 3005445717-2023-00006
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2023

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
• 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
• Patient Age: 70 YR
• Patient Sex: Male