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

Model Number	DDU-2400
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 their customer reported that their aed would not turn on.The aed was sent to the distributor, who attempted to turn on the device, but the battery pack was depleted and the aed would not power on.The maintenance schedule is not reported.Analysis of the log files found that the aed displayed 'no pad warning' multiple times.The device was unpowered for long periods of time.The customer's failure to promptly address red asi warnings reduced battery life expectancy.The customer was instructed that pads within their expiration date should always be attached.The aed should not flash red or beep.A replacement battery pack was inserted and the aed functioned as designed; aed is ok to remain in service, the customer should continue to monitor the device status.The ifu states: improper maintenance can cause the defibtech ddu series aeds not to function as designed.Maintain the 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.
Event or Problem Description
The distributor reported that their customer reported that their aed would not turn on.The aed was sent to the distributor, who attempted to turn on the device, but the battery pack was depleted and the aed would not power on.The reported event did not occur during patient use.

• 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: 19488739
• Report Number: 3003521780-2024-00591
• Device Sequence Number: 7024957
• Product Code: MKJ
• UDI-Device Identifier: 10815098020277
• UDI-Public: 10815098020277
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K121853
• 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): 05/10/2024

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-2400
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2015
• 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