MAUDE Adverse Event Report: DEFIBTECH LLC LIFELINE; AUTOMATED EXTERNAL DEFIBRILATOR

Model Number	DDU-E2400
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor reported that on mar 21st, their customer reported that the aed would not turn on.The customer had installed a battery pack on (b)(6) 2024.On mar 26th, the distributor received the aed from their customer and tested the batteries, the result were battery 1- the unit could not be tuned on.Battery's expiration date is 31-03-2028.Battery 2 -the unit could tun on and run self-test normally.The maintenance schedule is unknown.The customer was advised to continue to monitor the aed for any issues.The depleated battery pack will not be returned for further analysis.The ifu states: "warning: improper maintenance can cause the ddu-2400 series aed not to function.Maintain the ddu-24000 series aed only as described in the user manual and operating guide.The aed contains no user-serviceable parts- do not take the unit apart." "cautions: follow all battery pack labeling instructions.Do not install battery packs after the expiration date." the available information does not indicate that the device did not perform as intended or failed to meet product specifications.This device is used for treatment, not diagnosis.Should additional information become available a follow-up mdr shall be submitted.
Event or Problem Description
The distributor reported that their customer reported the aed's battery pack was unable to power it on.The battery that was in the aed has an expiration of 03/31/2028.Another battery pack was inserted and the aed worked as designed.No additional information provided.This reported event did not occur during patient use.
Additional Manufacturer Narrative
Analysis of the aed's log files identified that the customer's failure to promptly address red asi warnings reduced battery life expectancy.The cause of the aed not powering on was related to the customers failure to maintain the battery pack.As a follow up with the customer, the proper maintenance of this device was reviewed.Once the new battery was installed and a manual self test performed the aed functioned as designed and was able stay in service.

• Brand Name: LIFELINE
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILATOR
• Manufacturer (Section D): DEFIBTECH LLC; 741 boston post rd; suite 201; guliford 06437
• Manufacturer (Section G): DEFIBTECH LLC; 14 commercial st; branford CT 06405
• Manufacturer Contact: ian white ; 741 boston post rd; suite 201; guliford, CT 06437 ; 2034536654
• MDR Report Key: 24198619
• Report Number: 3003521780-2024-00358
• Device Sequence Number: 13147554
• Product Code: MKJ
• UDI-Device Identifier: 00815098020270
• UDI-Public: (01)00815098020270
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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 Number: DDU-E2400
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2017
• 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 Sex: Unknown