MAUDE Adverse Event Report: PHYSIO-CONTROL LUCAS¿ CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2018

Event Type  malfunction  

Event Description

The ambulance crew initiated cardiopulmonary resuscitation for a patient in cardiac arrest.The lucas chest compression system was applied to the patient according to the procedure.A general warning (red alarm triangle) light displayed on the lucas and the lucas did not work.The lucus was promptly removed from the patient and manual cpr was initiated.There was no harm to the patient.The lucus was brought to the biomedical engineering department for inspection.Biomedical engineering reported that they were unable to confirm the reported problem that the unit would not start and the red alarm triangle was illuminated.The device started and performed as intended on numerous tests.Biomed ran in continuous and 30:2 modes until the cooling fan activated.Biomed was unable to reproduce the problem and no problems were found.Lucus was returned to service.

• Brand Name: LUCAS¿ CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 7549954
• MDR Text Key: 109434060
• Report Number: 7549954
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: LAST PM WAS 1/18/18
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2018
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR