MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Catalog Number 11576-000080

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/09/2023

Event Type  malfunction  

Manufacturer Narrative

Stryker 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

The customer contacted stryker to report that their device's battery battery caught fire.This may lead to injury as a result of the fire.There was no patient involvement reported during the event.

Manufacturer Narrative

The customer received a replacement battery.The faulty battery was returned to stryker for investigation.The issue was able to be verified.The cause of the reported issue could not be determined.The faulty battery was archived by stryker.

Event Description

The customer contacted stryker to report that their device's battery battery caught fire.This may lead to injury as a result of the fire.There was no patient involvement reported during the event.

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18430024
• MDR Text Key: 331794049
• Report Number: 0003015876-2024-00006
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873861820
• UDI-Public: 00883873861820
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11576-000080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/09/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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