MAUDE Adverse Event Report: JOLIFE AB - 3005445717 UNKNOWN_MEDICAL - LUND_PRODUCT; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

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

Patient Problem Laceration(s) (1946)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Physio-control was made aware of the article "lund university cardiac assist system induced liver laceration and anterior cord infarction after cardiac arrest: a case report" published in a and a practice, that mentioned a patient event where the device use had potentially caused liver laceration and anterior cord infarction when it was used for prolonged cardiopulmonary resuscitation on a 21 year old male patient.The patient reached the emergency department 73 minutes after the onset of cardiac arrest, and return of spontaneous circulation (rosc) occurred 5 minutes after arrival.

Manufacturer Narrative

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr 3005445717-2020-00002.Physio-control contacted the author of the article to request additional information on the patient.No response has been received from the customer.A clinical review of the event was performed and it was determined that, based on the available information, manual cpr or the use of the device may have contributed to the liver laceration and anterior cord infarction.Device not evaluated by manufacturer.

• Brand Name: UNKNOWN_MEDICAL - LUND_PRODUCT
• 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: 16244026
• MDR Text Key: 308173678
• Report Number: 0003015876-2023-00136
• 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: Distributor
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2020,01/25/2023

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: UNK_LUN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Distributor Facility Aware Date: 01/01/2020
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2020
• Date Manufacturer Received: 01/08/2020
• 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): Other
• Patient Age: 21 YR
• Patient Sex: Male