MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 3

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  Death  

Manufacturer Narrative

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.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.

Event Description

A customer contacted stryker to report that their device gave an alarm and would not provide cardiopulmonary resuscitation during patient use.As a result, an unplanned pause in cardiopulmonary resuscitation would have occurred, if needed.The patient associated with the reported event did not survive.

Event Description

A customer contacted stryker to report that their device gave an alarm and would not provide cardiopulmonary resuscitation during patient use.As a result, an unplanned pause in cardiopulmonary resuscitation would have occurred, if needed.The patient associated with the reported event did not survive.

Manufacturer Narrative

Stryker evaluated the customer's device and was able to duplicate the reported issue.The customer has been issued a quote for repairs needed to resolve the reported issue.A clinical review was completed and no conclusion can be made regarding the contribution of the event on the patient's outcome due to insufficient information.Corrected data: the initial medwatch report indicated: g4: k161768.The initial medwatch report should indicate: g4: k173553.

• Brand Name: LUCAS 3 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: 18655852
• MDR Text Key: 334720907
• Report Number: 0003015876-2024-00278
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873834329
• UDI-Public: 00883873834329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173553
• 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: 02/06/2024,03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS 3
• 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: 01/09/2024
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 02/06/2024
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• 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: 95 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White