MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3, 3.0, IN SHIPPING BOX, EN; COMPRESSOR, CARDIAC, EXTERNAL

Model Number	LUCAS 3
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report a battery for one of their devices caught fire.The customer advised they were performing a routine check on their equipment and noticed smoke emitting from a battery that was in its charger.The customer removed the battery from the charger and placed it on the bay floor.The battery then caught on fire and engulfed the battery.The battery is used for an automated chest compression device.There was no patient use associated with the reported event.
Additional 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.
Additional Manufacturer Narrative
The battery was not returned to stryker for evaluation.The cause of the reported issue could not be determined.The customer received a replacement battery.H3 other text : device not returned to manufacturer.
Event or Problem Description
The customer contacted stryker to report a battery for one of their devices caught fire.The customer advised they were performing a routine check on their equipment and noticed smoke emitting from a battery that was in its charger.The customer removed the battery from the charger and placed it on the bay floor.The battery then caught on fire and engulfed the battery.The battery is used for an automated chest compression device.There was no patient use associated with the reported event.

• Brand Name: LUCAS 3, 3.0, IN SHIPPING BOX, EN
• Common Device Name: 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): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18335220
• Report Number: 0003015876-2023-02374
• Device Sequence Number: 6711991
• Product Code: DRM
• UDI-Device Identifier: 00883873861820
• UDI-Public: 00883873861820
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024
• Report Date (Section F): 12/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: LUCAS 3
• Device Catalogue Number: 99576-000043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2023
• Device Age: 0 MO
• Event Location: Other
• Date Report to Manufacturer: 12/12/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BATTERY,LUCAS,DARK GRAY.
• Patient Sex: Unknown