MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	DDU-2450
Medical Device Problem Codes	Failure to Power Up (1476); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported for their customer that the aed is depleting batteries prematurely.This is the second battery pack to be depleted before its expiration date.The customer did not report this event occurred during patient use.
Additional Manufacturer Narrative
The distributor reported for their customer that the aed is depleting batteries prematurely.They have two battery packs to become depleted before its expiration date.The battery pack expiration date is april 2028, the pads expiration date is not reported, and the maintenance schedule is not reported.The distributor sent a new battery pack to the customer in may 2024, and after the customer used the battery pack for a month, it was depleted.Although requested, the aed has not been returned and the cause of the complaint is not known.Should additional information become available, a follow-up mdr shall be submitted.No additional information is available at this time to further investigate the event.The ifu states: maintain the ddu 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.Follow all battery pack labeling instructions.Do not install battery packs after the expiration date.Follow all defibrillation pad label instructions.

• Brand Name: LIFELINE
• Common Device Name: 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 Key: 19998801
• Report Number: 3003521780-2024-00886
• Device Sequence Number: 12553641
• Product Code: MKJ
• UDI-Device Identifier: 10815098020314
• UDI-Public: 10815098020314
• 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,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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-2450
• Device Lot Number: 400077911
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/17/2024
• 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