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

Model Number	LUCAS 3
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2014029.(b)(4).Physio-control evaluated the customer¿s battery and verified the reported issue.Physio-control 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 or Problem Description
The customer contacted physio-control to report that their lucas 3 battery emitting an electrical smell and then the battery vented through the plastic shell.The device was in a paused and alarmed state.It was also reported that the device was warm to the touch with a new battery installed.There was no patient use associated with the reported event.Upon evaluation of the customer¿s battery, physio-control observed evidence of material leakage from the cells of the battery.Per the cell material safety data sheet, these materials include flammable organic solvents and corrosive irritants.Thus potential hazards include chemical burns from cell material exposure to sensitive tissues (eyes, skin, respiratory, gastro/respiratory) and for thermal burns resulting from ignition of vented battery cell flammable solvents.
Additional Manufacturer Narrative
E2014029.(b)(4).Physio-control further evaluated the battery and observed electrolyte residue, indicating electrolyte leakage from the cells.
Event or Problem Description
The customer contacted physio-control to report that their lucas 3 battery emitting an electrical smell and then the battery vented through the plastic shell.The device was in a paused and alarmed state.It was also reported that the device was warm to the touch with a new battery installed.There was no patient use associated with the reported event.Upon evaluation of the customer¿s battery, physio-control observed evidence of material leakage from the cells of the battery.Per the cell material safety data sheet these materials include flammable organic solvents and corrosive irritants.Thus potential hazards include chemical burns from cell material exposure to sensitive tissues (eyes, skin, respiratory, gastro/respiratory) and for thermal burns resulting from ignition of vented battery cell flammable solvents.

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Common Device Name: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• MDR Report Key: 8384307
• Report Number: 0003015876-2019-00363
• Device Sequence Number: 1975830
• Product Code: DRM
• UDI-Device Identifier: 00883873861875
• UDI-Public: 00883873861875
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K161768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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
• Device Lot Number: 2016-12-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2019
• Device Age: 2 YR
• Event Location: Ambulatory Surgical Facility
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1