MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; CARDIAC COMPRESSOR

Model Number RMU-1000

Device Problem Mechanical Problem (1384)

Patient Problem Unspecified Heart Problem (4454)

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

Analysis and testing of the returned device identified it was manufactured in 2019, performed a total of 148,259 compressions and had malfunctioned due to a damaged motor connector and damaged serial connector on the device's motor board.This mdr is being filed based on the discovery of this malfunction.

Event Description

A customer reported that during a rescue attempt, they went to use arm and when powered on, received the warning light and beeping.They reported they were not able to use the arm and used a backup arm for the rescue.Although the customer did not report the patient's outcome to the use of this device, this mdr is being filed as an adverse event, out of an abundance of caution.

• Brand Name: LIFELINE
• Type of Device: CARDIAC COMPRESSOR
• 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 dr.; branford CT 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06511 ; 2034536654
• MDR Report Key: 17063161
• MDR Text Key: 317553925
• Report Number: 3003521780-2023-00010
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141809
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Sex: Male