MAUDE Adverse Event Report: Defibtech, L.L.C. Lifeline; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number	DDU-120A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a rescue attempt involving a patient who had been removed from the water, the customer attempted to use the aed but experienced difficulty getting the defibrillation pads to adhere to the patient's wet, hairy chest.The fire department subsequently arrived, assumed responsibility for the rescue, and used its own equipment.The customer stated that the aed did not malfunction and clarified that the purpose of the inquiry was to replace the pads used during the rescue and potentially purchase additional spare sets.No information regarding the patient's condition or outcome was provided.
Additional Manufacturer Narrative
This event is being reported as a malfunction because the reported inability of the defibrillation pads to adhere adequately, if it were to recur, could delay or prevent the delivery of defibrillation therapy and could cause or contribute to a death or serious injury.The customer had disposed of the defibrillation pads used during the rescue attempt and did not provide the pad lot number or expiration date.The customer attributed the reported difficulty with pad adhesion to the patient's wet skin and excess chest hair.The ddu-120 series operating guide instructs users to remove clothing from the patient's chest and, if necessary, dry the chest and remove excess chest hair.The guide also warns that contact between the patient's body and conductive fluids"[?]"including water, gel, blood, or saline"[?]"or metal objects may provide unwanted pathways for defibrillating current.Because the pads were not returned and the lot number and expiration date were unavailable, the reported issue could not be reproduced or evaluated.Although the conditions reported by the customer may have contributed to the difficulty with pad adhesion, a definitive root cause could not be confirmed.

• Brand Name: Lifeline
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS
• 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
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; +1(203)453-6654
• MDR Report Key: 50438828
• Report Number: 3003521780-2026-01397
• Device Sequence Number: 21229521
• Product Code: MKJ
• UDI-Device Identifier: 00815098020041
• UDI-Public: (01)00815098020041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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 Model Number: DDU-120A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 190 LB