MAUDE Adverse Event Report: STRYKER/ JOLIFE AB LUCAS 3.1; COMPRESSOR, CARDIAC, EXTERNAL

Device Problems Battery Problem (2885); Intermittent Energy Output (4025)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 06/19/2023

Event Type  Injury  

Event Description

Stryker lucas cpr device 3.1 failed to perform mechanical cpr after about 2 minutes of operation.Battery was showing end of life but still good.Failed with second battery also.Reference report: mw5118761.

• Brand Name: LUCAS 3.1
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): STRYKER/ JOLIFE AB
• MDR Report Key: 17198485
• MDR Text Key: 317947742
• Report Number: MW5118760
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White