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

Model Number LUCAS

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 10/12/2022

Event Type  Injury  

Event Description

The customer contacted stryker to report that they were using their device on a patient and it "punched a hole through the patient's chest.".

Manufacturer Narrative

The customer informed stryker that no further patient information is available.Patient fields in which information was not provided were intentionally left blank.Stryker performed a clinical review of the reported event and determined that the device likely caused the cut/hole in the patient's chest; however, this likely didn't impact the outcome of the patient.The device was not returned to stryker or jolife for evaluation.The cause of the reported issue could not be determined.

Manufacturer Narrative

Stryker evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.

Event Description

The customer contacted stryker to report that they were using their device on a patient and it "punched a hole through the patient's chest.".

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL / DRM
• 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: 15760929
• MDR Text Key: 303333690
• Report Number: 0003015876-2022-02459
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022,03/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/12/2022
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 10/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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): Other