MAUDE Adverse Event Report: STRYKER / JOLIFE AB LUCAS 3; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 3

Device Problems Energy Output Problem (1431); Unexpected Shutdown (4019)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/18/2022

Event Type  Injury  

Event Description

The paramedic crew reported that the lucas 3 stopped compressions and turned off 3 times during cardiac arrest.Fda safety report id# (b)(4).

• Brand Name: LUCAS 3
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): STRYKER / JOLIFE AB
• MDR Report Key: 14311742
• MDR Text Key: 291205937
• Report Number: MW5109557
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS 3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White