MAUDE Adverse Event Report: JOLIFE AB/ PHYSIO-CONTROL, INC. LUCAS DEVICE CPR; COMPRESSOR, CARDIAC, EXTERNAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Breakdown (2681)

Event Date 07/03/2019

Event Type  malfunction  

Event Description

On arrival to the emergency room, a significant breakdown of the skin on patient's chest from the thumper of the lucas chest compression system was noted.Ems ad ministration notified.Fda safety report id # (b)(4).

• Brand Name: LUCAS DEVICE CPR
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB/ PHYSIO-CONTROL, INC.
• MDR Report Key: 8794008
• MDR Text Key: 151328795
• Report Number: MW5088159
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Weight: 70