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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 Complete Loss of Power (4015)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Defibtech is attempting to attain a copy of the electronic data from the device.To date, however, the electronic data has not been received.The investigation is currently on-going, and no root cause is known.Should additional information become available, a follow-up mdr will be submitted.
 
Event or Problem Description
An ambulance company reported that the battery stopped working in the device during a rescue however a spare battery was used, and they were able to continue the rescue.It was not known if there was a death or serious injury associated with the event and no additional event or patient details were provided.
 
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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 Key8511371
Report Number3003521780-2019-00008
Device Sequence Number14152656
Product Code DRM
UDI-Device Identifier00815098020539
UDI-Public00815098020539
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
K141809
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/19/2019
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 NumberRMU-1000
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/19/2019
Initial Report FDA Received Date04/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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