MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM; 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 01/29/2024

Event Type  Death  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.A clinical review was performed and the device use may have caused or contributed to the patient's outcome.As described, injuries to the liver occur with both manual and mechanical cpr.From this reported case it can not be excluded that the liver injury was caused by compressions from the lucas device.Stryker 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 stryker to report that the use of the device had caused suspicious bleeding and that, after biopsy, two lacerations were observed in the patient's liver.The patient associated with the reported event did not survive.

Manufacturer Narrative

Additional information: the customer confirmed they do not believe there's anything wrong with the device, at this time, therefore it will not be returned for evaluation.The customer was contacted for additional information related to the event and reported that the ct scan shows signs of cerebral oedema because of the massive pulmonary embolism and cardiac arrest.The customer does not know if the patient would have recovered from this if she had survived the bleeding which was caused by the lucas device.Corrected data: section e, initial reporter name of the initial medwatch report indicates: (b)(6); section e, initial reporter name of the initial medwatch report should indicate: (b)(6).Section e1, initial reporter facility of the initial medwatch report indicates: (b)(6).Section e1, initial reporter facility of the initial medwatch report should indicate: (b)(6).Section e1, initial reporter first name of the initial medwatch report indicates: (b)(6); section e1, initial reporter first name of the initial medwatch report should indicate: (b)(6).Section e1, initial reporter last name of the initial medwatch report indicates: (b)(6); section e1, initial reporter last name of the initial medwatch report should indicate: (b)(6).Section e1, initial reporter phone of the initial medwatch report indicates: (b)(6) ; section e1, initial reporter phone of the initial medwatch report should indicate: (b)(6).Section e1, initial reporter email of the initial medwatch report indicates: (b)(6); section e1, initial reporter email of the initial medwatch report should indicate: (b)(6).Section e1, initial reporter address of the initial medwatch report indicates: (b)(6) ; section e1, initial reporter address of the initial medwatch report should indicate: (b)(6).Section e1, initial reporter city of the initial medwatch report indicates: (b)(6); section e1, initial reporter city of the initial medwatch report should indicate: (b)(6).Section e1, initial reporter postal code of the initial medwatch report indicates: (b)(6) ; section e1, initial reporter postal code of the initial medwatch report should indicate: (b)(6).Section e2, health professional of the initial medwatch report indicates: no; section e2, health professional of the initial medwatch report should indicate: yes.Section e3, health professional occupation of the initial medwatch report indicates: non-healthcare professional; section e3, health professional occupation of the initial medwatch report should indicate: other healthcare professional.Section e3, h p occupation - other of the initial medwatch report should indicate: doctor.

Event Description

A customer contacted stryker to report that the use of the device had caused suspicious bleeding and that, after biopsy, two lacerations were observed in the patient's liver.The patient associated with the reported event did not survive.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18710646
• MDR Text Key: 335465237
• Report Number: 3005445717-2024-00005
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 99576-000026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2015
• 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): Death
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: Black Or African American