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

Model Number LUCAS

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

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 04/06/2021

Event Type  Death  

Manufacturer Narrative

Physio-control contacted the customer 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.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) (b)(4) of the european parliament and of the council.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.

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 patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.

Manufacturer Narrative

Section d4, serial no of the initial medwatch report indicates (b)(6).Section d4, serial no of the initial medwatch report should indicate (b)(6).Section h4, manufacturing date of the initial medwatch report indicates 11/13/2019.Section h4, manufacturing date of the initial medwatch report should be 10/31/2019.

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 patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.

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 patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.

Manufacturer Narrative

The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.The device was evaluated in august 2021 and the device passed all functional and performance testing.

Manufacturer Narrative

The sales representative informed that the serial number was reported in error and that it is unknown.Section d4, serial no of the initial medwatch report indicates (b)(6).Section d4, serial no of the initial medwatch report should indicate unknown.Section h4, manufacturing date of the initial medwatch report indicates 10/31/2019.Section h4, manufacturing date of the initial medwatch report should be blank.

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 patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.

Manufacturer Narrative

Section h10 and/or 11, additional mfg narrative of the supplemental medwatch report (002) indicates the customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.The device was evaluated in august 2021 and the device passed all functional and performance testing.Section h10 and/or 11, additional mfg narrative of the supplemental medwatch report (002) should indicate a stryker clinical specialist performed a clinical review and it was determined that due to lack of information it can not be excluded or confirmed that the reported injuries could have been caused by cpr, manual or mechanical.The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.

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 patient had chest hemorrhage with ascending aorta adventitial dissection with cardiac tamponade, pericardial tearing with myocardial hemorrhage and bruising.The patient associated with the reported event did not survive.

• Brand Name: LUCAS ® 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: 11814364
• MDR Text Key: 250272935
• Report Number: 3005445717-2021-00006
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/12/2021,07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 99576-000065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 05/12/2021
• Distributor Facility Aware Date: 10/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 09/02/2021; 10/27/2021; 12/21/2021; 06/30/2022
• Supplement Dates FDA Received: 09/29/2021; 11/24/2021; 01/21/2022; 07/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2019
• 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: 62 YR
• Patient Sex: Male