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 06/14/2021

Event Type  Death  

Manufacturer Narrative

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under 3005445717-2021-00010.Due to character limitations initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.   though physio-control requested some patient information, physio will not request any information which can identify, directly or indirectly, a person to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.A physio-control service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.After completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Clinical review of the reported event was performed.It can not be excluded that the failing of the device contributed to the patient death even if the survival rate in this transported patient population is low.

Event Description

A customer contacted physio-control to report that their device failed during intervention on a patient.The device alarmed and stopped.The patient did not survive reported event.The healthcare provider confirmed that the device use contributed to the patient 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: 16237076
• MDR Text Key: 308063582
• Report Number: 3005445717-2023-00031
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• 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: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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: 37 YR
• Patient Sex: Male