MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LUCAS; COMPRESSOR, CARDIAC, EXTERNAL

Model Number 81498

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 09/11/2019

Event Type  malfunction  

Event Description

Lucas device started beeping and stopped working while using device on patient.Lucas device had full battery but failed to work.Lucas device removed from patient and manual cpr initiated in less than 10 seconds after device malfunctioned.Lucas id (b)(4).

• Brand Name: LUCAS
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows rd ne; redmond WA 98052
• MDR Report Key: 9510823
• MDR Text Key: 172438825
• Report Number: 9510823
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/16/2019

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: No Information
• Device Model Number: 81498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Type of Device Usage: N
• Patient Sequence Number: 1