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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 Unspecified Heart Problem (4454)
Event Type  malfunction  
Manufacturer Narrative
An inspection of the returned device identified that the the root cause was attributed to loosening of the rmu-1000 motor's bottom screw.
 
Event Description
An international distributor reported that when a customer was using the arm with the patient, the device stopped working.No patient details were provided.They reported that after the event they checked the device's report and found the following warnings: "warn - motor should be home" and "warn - motor didn't move in time".
 
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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 Key16117472
MDR Text Key308460011
Report Number3003521780-2023-00001
Device Sequence Number1
Product Code DRM
UDI-Device Identifier10815098020628
UDI-Public10815098020628
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 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2023
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 Manufacturer12/01/2022
Date Manufacturer Received12/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2020
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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