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

Model Number LUCAS 3

Device Problem Noise, Audible (3273)

Patient Problem Loss of consciousness (2418)

Event Date 06/28/2022

Event Type  Death  

Event Description

Patient was seen in ed and needed admission, patient was waiting ms bed.Ed was running short staffed with cm and acm working the floor to aid staffing.When snt went to evaluate patient he was found to be unresponsive.Code was initiated.When placing ed stryker lucas3 device, device did not function, device sounded as if it was trying to work but was not providing any compressions.Second stryker lucas3 device was retrieved and initiated.This caused a delay in care in a coding patient.Patient did not survive the code.Fda safety report id # (b)(4).

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): STRYKER / JOLIFE AB
• MDR Report Key: 14914569
• MDR Text Key: 295328078
• Report Number: MW5110651
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS 3
• 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 Sex: Male