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 09/11/2023

Event Type  malfunction  

Event Description

A customer reported that while running a code, the rmu-1000 ceased performing compressions, followed by the warning and maintenance lights going off and beeping.They attempted to troubleshoot on scene but resorted to manual compressions.

Manufacturer Narrative

Analysis of the returned device confirmed the customer complaint as the compressions module was unable to find its home position and the piston would not extend.Further analysis identified that the unit had malfunctioned due to a damaged motor connector on the device's motor board.This mdr is being filed based on the discovery of this malfunction.

• 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: 17916424
• MDR Text Key: 326253289
• Report Number: 3003521780-2023-00023
• 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: 09/12/2023

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 Operator: Health Professional
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/11/2023
• 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: Unknown
• Patient Sequence Number: 1