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

Model Number DDU-100

Device Problem No Audible Prompt/Feedback (2282)

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

Event Type  malfunction  

Event Description

A customer reported their aed will not speak after upgrading software.They reported this 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: 19140779
• MDR Text Key: 340585370
• Report Number: 3003521780-2024-00345
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 01081509020031
• UDI-Public: 1081509020031
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P160032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2019
• 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