MAUDE Adverse Event Report: JOLIFE AB LUCAS; CHEST COMPRESSION DEVICE

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Bone Fracture(s) (1870)

Event Date 04/12/2015

Event Type  Injury  

Event Description

Pt went into cardiac arrest in the emergency department.The lucas device was used to perform the chest compressions.It was discovered a few weeks later that the pt had a fracture of t7 vertebra and left ribs 3-6.

• Brand Name: LUCAS
• Type of Device: CHEST COMPRESSION DEVICE
• Manufacturer (Section D): JOLIFE AB; scleelev, 17; lund se SE-2 23
• MDR Report Key: 4917672
• MDR Text Key: 6014103
• Report Number: MW5044182
• Device Sequence Number: 1
• Product Code: DRM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 86