JOLIFE AB - 3005445717 LUCAS 2, 2.2, IN SHIPPING BOX,EN,DA,SV,FI,NO; COMPRESSOR, CARDIAC, EXTERNAL
|
Back to Search Results |
|
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 # 0003015876-2020-00156.Physio-control contacted the author of the article 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.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.The root cause could not be determined, but based on the information provided there was no indication of a device malfunction.Device not evaluated by manufacturer.
|
|
Search Alerts/Recalls
|
|
|