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

Catalog Number 99576-000024

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

Patient Problems Death (1802); Laceration(s) (1946); Liver Laceration(s) (1955)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The device's serial number was not provided.The device was not returned to physio-control for evaluation.Based on the information provided, there was no indication of a device malfunction.Physio-control has attempted to contact the customer in order to obtain additional information regarding the event, how the device was used, and if a stabilization strap was utilized to secure the correct position during operation.No response has been received.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.

Event Description

Physio-control was made aware of the article "severe intra-abdominal lesions resulting from cardiac lung rescue with lucas chest compression system" published in danish medical journal "ugeskr laeger", that mentioned a patient event where the device use had potentially caused liver laceration, spleen fracture/ spleen artery lesion and a distal pancreatic lesion.The patient expired four days later.

• Brand Name: LUCAS 2 CPR 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; SE SE-223 70
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• Manufacturer Contact: meg marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 8588946
• MDR Text Key: 144385177
• Report Number: 0003015876-2019-00796
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873904565
• UDI-Public: 00883873904565
• Combination Product (y/n): N
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 99576-000024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• 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
• Patient Age: 72 YR