MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; EXTERNAL CARDIAC COMPRESSOR

Model Number LUCAS

Device Problem Sharp Edges (4013)

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

Event Date 01/21/2023

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information was 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

The customer contacted stryker to report that their device had plastic fragments on the edges of its suction cup that caused three lacerations to a patient.The patient involved in the reported event is also deceased from cardiac arrest.

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Type of Device: EXTERNAL CARDIAC COMPRESSOR
• 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: 19113768
• MDR Text Key: 341003037
• Report Number: 3005445717-2024-00007
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873834329
• UDI-Public: 00883873834329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161768
• 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
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000063
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2023
• 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