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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEFIBTECH, L.L.C. REVIVER; AUTOMATED EXTERNAL DEFIBRILLATOR
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DEFIBTECH, L.L.C. REVIVER; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number DDU-100
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A customer reported that their aed has a possible speaker issue.They reported this did not occur during patient use.
 
Manufacturer Narrative
The investigation of the aed associated with this complaint is underway and the root cause is not currently known.Should additional information become available a follow-up mdr shall be submitted.
 
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Brand Name
REVIVER
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 Key19198563
MDR Text Key341464801
Report Number3003521780-2024-00376
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier10815098020024
UDI-Public10815098020024
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/28/2024
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
Device Model NumberDDU-100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2024
Initial Date Manufacturer Received 03/28/2024
Initial Date FDA Received04/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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