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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; CARDIAC COMPRESSOR
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DEFIBTECH, L.L.C. LIFELINE; CARDIAC COMPRESSOR Back to Search Results
Model Number RMU-1000
Medical Device Problem Code Charging Problem (2892)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The investigation is on-going.No root cause has been determined at this time.Should additional information become available a follow-up mdr will be submitted.
 
Event or Problem Description
A customer reported a squealing sound while charging the compression module in its carry bag.They reported that when they opened the carry bag, they saw smoke, but were not sure if the charger or the compression module were smoking.Although this did not occur during patient use and there was no patient involvement, this mdr is being filed out of an abundance of caution.
 
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Brand Name
LIFELINE
Common Device Name
CARDIAC COMPRESSOR
Manufacturer (Section D)
DEFIBTECH, L.L.C.
741 boston post rd.
suite 201
guilford CT 06437
MDR Report Key8651419
Report Number3003521780-2019-00011
Device Sequence Number11374064
Product Code DRM
UDI-Device Identifier00815098020539
UDI-Public00815098020539
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K141809
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/01/2019
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 No Information
Device Model NumberRMU-1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/01/2019
Initial Report FDA Received Date05/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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