MAUDE Adverse Event Report: DEFIBTECH LLC LIFELINE; AUTOMATED EXTERNAL DEFIBRILATOR

Model Number DDU-100

Device Problem Battery Problem (2885)

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

Event Type  malfunction  

Manufacturer Narrative

Communication with the customer did not identify the cause for the depleted battery pack.The customer installed a backup battery pack and the aed functioned as designed.The maintenance schedule for the aed is not known.The customer was advised order a replacement battery pack from distributor, keep pads connected, verify the asi flashing green.The aed can be returned to service after these items are completed.As the battery pack is out of warranty it will not be returned for analysis; the cause of the complaint cannot be determined.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 defibrillation 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.

Event Description

The customer reported that when checking aed, they received a warning of 'battery pack voltage' and was unable to power on the aed.The battery expiration is 09/30/24 and the pads have an expiration date of 04/30/24.The customer installed a back-up battery pack and the aed functioned as designed.No additional information provided.This reported event did not occur during patient use.

• Brand Name: LIFELINE
• Type of Device: 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 ; 2034536654
• MDR Report Key: 19198360
• MDR Text Key: 341602519
• Report Number: 3003521780-2024-00368
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

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: 03/27/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2018
• 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