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

Model Number LUCAS 2

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

Patient Problems Hemorrhage/Bleeding (1888); Multiple Fractures (4519)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control performed a clinical review and it was determined that it can not be excluded that some of the injuries were caused by lucas cpr.Lucas was not believed to have contributed to the patient´s death.Physio-control performed an initial evaluation of the customer's device and no malfunction was observed.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the thoracic ribs had multiple fractures, heart wall had hemorrhages and the bronchus had torn.The patient associated with the reported event did not survive, however the customer confirmed that the device did not contribute to the patient death.

Manufacturer Narrative

The device passed functional and performance testing and was returned to the customer.Root cause of the reported injury remain unknown, however broken ribs and sternal fracture is a side affect of cpr and the use of the lucas device.Furthermore, the customer noted that stabilization straps were not used as instructed in the oi.The stabilization strap secures the position of the device in relation to the patient to ensure correct positioning over chest.If the pressure pad is not in the correct position in relation to the sternum, there is an increased risk of damage to the rib cage and internal organs.

Event Description

A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the thoracic ribs had multiple fractures ,heart wall had hemorrhages and the bronchus had torn.The patient associated with the reported event did not survive, however the customer confirmed that the device did not contribute to the patient death.

• 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; 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: 12239054
• MDR Text Key: 263847845
• Report Number: 3005445717-2021-00012
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2021,11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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: 99576-000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2021
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• 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
• Patient Age: 73 YR
• Patient Sex: Male