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

Model Number LUCAS 3

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

(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 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.

Manufacturer Narrative

(b)(4).Physio-control further evaluated the battery and observed electrolyte residue, indicating electrolyte leakage from the cells.

Event 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
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• Manufacturer Contact: meg marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 8384307
• MDR Text Key: 137825036
• Report Number: 0003015876-2019-00363
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873861875
• UDI-Public: 00883873861875
• 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,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2019
• Device Age: 2 YR
• Event Location: Ambulatory Surgical Facility
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• 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