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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3, 3.0, IN SHIPPING BOX, EN; COMPRESSOR, CARDIAC, EXTERNAL
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JOLIFE AB - 3005445717 LUCAS 3, 3.0, IN SHIPPING BOX, EN; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
Model Number LUCAS 3
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2023
Event Type  malfunction  
Event 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.
 
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.
 
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 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.
 
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Brand Name
LUCAS 3, 3.0, IN SHIPPING BOX, EN
Type of Device
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)
JOLIFE AB - 3005445717
scheelevagen 17
ideon science park
lund SE-22 3 70
SW   SE-223 70
Manufacturer Contact
dara friedman
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key18335220
MDR Text Key330602654
Report Number0003015876-2023-02374
Device Sequence Number1
Product Code DRM
UDI-Device Identifier00883873861820
UDI-Public00883873861820
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161768
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/12/2023,12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLUCAS 3
Device Catalogue Number99576-000043
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/12/2023
Device Age0 MO
Event Location Other
Date Report to Manufacturer12/12/2023
Date Manufacturer Received12/12/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
BATTERY,LUCAS,DARK GRAY.
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