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

Model Number DDU-120

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 maintenance schedule is not known.The customer was advised to get a new battery pack and a 9v lithium battery.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-120 series aed not to function.Maintain the ddu-120 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." should additional information become available a follow-up mdr shall be submitted.

Event Description

The customer reported that their aed will not power on.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: 19187828
• MDR Text Key: 341383626
• Report Number: 3003521780-2024-00353
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 10815098020048
• UDI-Public: 10815098020048
• 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: 03/25/2024

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-120
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2019
• 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