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

Model Number DDU-100

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported that the aed unit was used during a rescue, no issues during use.After this use, there was a service code indicating 'rtc time ok'.Unit was not evaluated or removed from service.When they were going to use it for a different rescue attempt they still had service code 'rtc time ok'.Unit was turned off after the second service code warning, as the battery was depleted.There was no reported patient injury or adverse event.

Manufacturer Narrative

The battery pack associated with this complaint was not returned for analysis, and the root cause cannot be determined.Troubleshooting of the aed with the customer identified that the aed is functioning as designed and can stay in service.The ifu states: "improper maintenance can cause the ddu-100 series aed not to function.Maintain the ddu-100 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 defi brillation pad label instructions.Use defibrillation pads prior to their 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
• Type of Device: 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: 19188714
• MDR Text Key: 341619717
• Report Number: 3003521780-2024-00367
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 10815098020000
• UDI-Public: 10815098020000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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-100
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1