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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
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
An inspection of the returned device identified that the root cause was attributed to a damaged motor connector.
 
Event Description
An international distributor reported that their customer found a warning of "!" after they turned on the unit.They tried to turn off and, on the unit, again but the warning still occurred.They reported that this did not occur while using the device on a patient.
 
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Brand Name
LIFELINE
Type of Device
CARDIAC COMPRESSOR
Manufacturer (Section D)
DEFIBTECH, L.L.C.
741 boston post rd.
suite 201
guilford CT 06437
Manufacturer (Section G)
DEFIBTECH, L.L.C.
741 boston post road
suite 201
guilford CT 06437
Manufacturer Contact
ian white
741 boston post road
suite 201
guilford, CT 06437
2034536654
MDR Report Key16178859
MDR Text Key308856000
Report Number3003521780-2023-00002
Device Sequence Number1
Product Code DRM
UDI-Device Identifier10815098020536
UDI-Public10815098020536
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K141809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 09/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberRMU-1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2022
Date Manufacturer Received12/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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