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

Model Number	DBP-1400
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their battery has an expirtion date in 2025, but the battery is dead.The serial number for the aed was not provided.The reported event did not occur during patient use.
Additional Manufacturer Narrative
Communication with the customer did not identify the cause for the depleted battery pack.The maintenance schedule is not known.No additional information is available to further inveigate the event.As the battery pack will not be returned for analysis the cause of the complaint cannot be determined.The ifu states: improper maintenance can cause the defibtech ddu series aed 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.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.

• 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: 19346971
• Report Number: 3003521780-2024-00493
• Device Sequence Number: 19478342
• Product Code: MKJ
• UDI-Device Identifier: 00815098020362
• UDI-Public: 00815098020362
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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 Expiration Date: 02/28/2025
• Device Model Number: DBP-1400
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2019
• 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