MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS¿ CPR CHEST COMPRESSION SYSTEM; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number LUCAS

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/22/2022

Event Type  Injury  

Event Description

The customer contacted stryker to report they observed airway damage (bleeding) on patient after use of their device.It is unknown if the device did or did not cause or contribute to this event.

Manufacturer Narrative

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr # 3005445717-2022-00002.Stryker received additional patient information from the customer.The customer provided stryker with the available patient information.The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.Stryker evaluated the information provided by the customer and concluded that with the limited information received it cannot be excluded that the airway bleeding occurred during the compressions from lucas device.A complete clinical review could not be conducted with the available information.It is mentioned in the lucas 3 instructions for use (ifu) in section 2.4 side effects that: "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.After resuscitation, all patients should be reassessed and reevaluated for resuscitation-related injuries." device not evaluate by the manufacturer.

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS
• 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: 16131464
• MDR Text Key: 307009257
• Report Number: 0003015876-2023-00039
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2022,01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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: 99576-000063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2022
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 03/22/2022
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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