MAUDE Adverse Event Report: Defibtech LLC Lifeline; Automated External Defibrilator

Model Number	DDU-120
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Cancer (3262); Unspecified Heart Problem (4454)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the aed did not power on when deployed for a rescue attempt.The reported event occurred during patient use.The customer stated that they rarely need to use aeds, so it wasn't being maintained at all.This patient had terminal cancer and when their aed did not power on ems tried to use their aed (not defibtech) and he did not have a shockable rhythm and no shock was advised nor delivered.The patient was pronounced dead at the hospital.Although the patient was not resuscitated in this case, the patient's death is not attributed to this device problem.
Additional Manufacturer Narrative
The customer reported the aed did not power on during a rescue attempt.The customer stated that the aed was stored on the crash cart, they rarely need to use aeds so it wasn't being maintained at all.This patient had terminal cancer and when the aed did not power on, ems tried to use their aed (not a defibtech device) and the patient had no shockable rhythm- no shock advised.The patient was pronounced deceased at the hospital.The aed was not being maintained in accordance with the manufacturer's ifu.Discussed proper maintenance and advised the customer to purchase new battery pack.No additional information is available to to further investigate the event.The ifu states: improper maintenance can cause the ddu series aeds not to function.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.Use defibrillation pads prior to their expiration date.The available information does not reasonably suggest 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.

• 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 ; +1(203)453-6654
• MDR Report Key: 50192576
• Report Number: 3003521780-2024-00618
• Device Sequence Number: 9915344
• Product Code: MKJ
• UDI-Device Identifier: 10815098020048
• UDI-Public: 10815098020048
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: DDU-120
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 100 LB