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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; AUTOMATED EXTERNAL DEFIBRILLATOR
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DEFIBTECH, L.L.C. LIFELINE; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number DDU-100
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Heart Problem (4454)
Event Date 03/08/2024
Event Type  malfunction  
Manufacturer Narrative
Analysis of the log files from the aed is ongoing and the cause of the complaint is not known.Should additional information become available a follow-up mdr shall be submitted.
 
Event Description
A customer reported that during a rescue attempt the aed canceled the shock six times in total.It was reported that the patient was not resuscitated.
 
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Brand Name
LIFELINE
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
DEFIBTECH, L.L.C.
741 boston post rd.
suite 201
guilford CT 06437
Manufacturer (Section G)
DEFIBTECH, L.L.C.
14 commercial st.
branford CT 06405
Manufacturer Contact
ian white
741 boston post road
suite 201
guilford, CT 06437
2034536654
MDR Report Key19102038
MDR Text Key340181562
Report Number3003521780-2024-00293
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier10815098020031
UDI-Public10815098020031
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
P160032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberDDU-100
Initial Date Manufacturer Received 03/14/2024
Initial Date FDA Received04/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
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