MAUDE Adverse Event Report: STRYKER CORP / JOLIFE AB STRYKER LUCAS II AUTOMATED COMPRESSION DEVICE; COMPRESSOR, CARDIAC, EXTERNAL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2022

Event Type  Death  

Event Description

Automated compression device was placed to perform chest compressions during a cpr event.Product did not work and was replaced with another device from a different unit which worked properly.Fda safety report id# (b)(4).

• Brand Name: STRYKER LUCAS II AUTOMATED COMPRESSION DEVICE
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): STRYKER CORP / JOLIFE AB
• MDR Report Key: 14345479
• MDR Text Key: 291356622
• Report Number: MW5109598
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: American Indian Or Alaskan Native