MAUDE Adverse Event Report: JOLIFE AB LUCAS; COMPRESSOR, CARDIAC, EXTERNAL

Device Problems Device Inoperable (1663); Battery Problem (2885); Device Operates Differently Than Expected (2913)

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

Event Date 04/21/2017

Event Type  malfunction  

Event Description

An emergency department patient when into cardiac arrest.An automatic chest compression system was placed on the patient and malfunctioned.The malfunction noted was that the system showed a full battery, but after about two minutes in use, one of the battery lights turned orange and the unit made an alarming sound.A staff member replaced the battery, and after another two minutes of use with a new battery, and again, the battery light turned orange and the alarm sounded.The system was removed from the patient while manual compression were performed.The malfunction resulted in a staff member having to leave the patient's side to find another chest compression system.There was no adverse outcome for the patient related to the failure of the initial chest compression system.The chest compression system was pulled from service and brought to the biomedical engineering department.Follow up: the affected chest compression system was purchased in approx 2 years ago and the last preventative maintenance was completed by the manufacturer less than 1 year ago.Biomedical engineering contacted the manufacturer and requested service on the device after they were unable to reproduce the reported problem.When tested, the device ran as intended.The manufacturer next tested the unit and also could not replicate the complaint.They reseated all connections and reloaded software 2.2.Performed performance inspection procedure and all checks were ok.Unit returned to service.

• Brand Name: LUCAS
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; 11811 willows rd. ne; redmond WA 98052
• MDR Report Key: 6550994
• MDR Text Key: 74602032
• Report Number: 6550994
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR