MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Date 01/15/2021

Event Type  Death  

Manufacturer Narrative

This mdr is being submitted to correct the incorrect fda registration number that was previously submitted under uf/importer report number # 3005445717-2021-00007.The customer was contacted by stryker, however they could not provide a serial number for the device involved.The customer stated that there was no suspected device failure , however it is alleged that the device caused the serious injury and may have contributed to the death.The device could not be evaluated so no root cause could be determined for the reported patient injury.The device remains with the customer.Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.H3 other text : device not returned to manufacturer.

Event Description

A customer contacted physio-control to report that their device was used during transport and in the emergency room for an hour long cpr.Autopsy showed fractures of the sternum with secondary lacerations of the aorta resulting in bleeding.There was no observed malfunction during the event.The patient did not survive the event, but the customer confirmed this does not mean it was the primary cause of death.

• Brand Name: LUCAS 2 CHEST COMPRESSION SYSTEM
• 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: 16237501
• MDR Text Key: 308064082
• Report Number: 0003015876-2023-00124
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 01/24/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS 2
• Device Catalogue Number: 99576-000026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2021
• Device Age: 0 YR
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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