MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2, 2.1 SW, IN SHIPPING BOX,EN,EN INTL; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2019

Event Type  Death  

Event Description

The customer contacted physio-control to report that their device blocked during patient use.The users tried to restart the device, but it did not resolve the issue.Subsequently, manual cpr was provided, but it was reported that the reported issue delayed the treatment of the patient.The patient passed away a few days after the event at the intensive care unit.

Manufacturer Narrative

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr 0003015876-2020-00009.Physio-control evaluated the customers device and was unable to duplicate the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.A clinical review was performed and concluded that the interruption in cpr might have been too long due to non-compliance to the instruction for use, the rescuer should have started manual cpr directly according to the instruction for use.Use of the lucas device may have contributed to the patient¿s outcome.

• Brand Name: LUCAS 2, 2.1 SW, IN SHIPPING BOX,EN,EN INTL
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16243933
• MDR Text Key: 308128137
• Report Number: 0003015876-2023-00134
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2020,01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2020
• Distributor Facility Aware Date: 11/01/2019
• Device Age: 13 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG