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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL / DRM
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JOLIFE AB - 3005445717 LUCAS 2 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL / DRM Back to Search Results
Model Number LUCAS
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Manufacturer Narrative
The battery was returned to stryker and a visual inspection confirmed the reported issue.No root cause could be determined.
 
Event Description
The customer contacted physio-control to report that their device's battery and charging station accessories caught fire.There was no patient involvement reported with the event.
 
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Brand Name
LUCAS 2 CHEST COMPRESSION SYSTEM
Type of Device
COMPRESSOR, CARDIAC, EXTERNAL / DRM
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
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key15921126
MDR Text Key304864883
Report Number3005445717-2022-00007
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161768
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLUCAS
Device Catalogue Number11576-000080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2022
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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