MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3, 3.1, IN SHIPPING BOX, EN; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr 0003015876-2019-01741.Physio-control evaluated the customers device and was unable to duplicate the reported issue.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.

Event Description

The customer contacted physio-control to report that their device caused extensive trauma to patients, with one incident involving a sternal fracture which resulted in cardiac laceration.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

• Brand Name: LUCAS 3, 3.1, IN SHIPPING BOX, EN
• 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: 16243611
• MDR Text Key: 308126996
• Report Number: 0003015876-2023-00131
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019,01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2019
• Distributor Facility Aware Date: 09/25/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2019
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Other