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 Liver Laceration(s) (1955)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

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.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.: device not evaluated by manufacturer.

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 (b)(6)-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

The root cause could not be determined, but based on the information provided there was no indication of a device malfunction.

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.

• 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; SE SE-223 70
• MDR Report Key: 9653730
• MDR Text Key: 177268200
• Report Number: 3005445717-2020-00002
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/08/2020,06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2020
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2020
• Date Manufacturer Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR