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

Model Number RMU-1000

Device Problem Mechanical Problem (1384)

Patient Problem Cardiac Arrest (1762)

Event Date 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

Analysis of the device's electronic history file showed the device was manufactured in december 2020 and during its service, had performed 32,059 compressions.Analysis of the returned device identified the cause of the reported problem was caused by the loosening of the compression module's bottom screw.

Event Description

An international distributor relayed a report from a professional user that the compression device stopped performing compressions during use.It was also reported that there was no death or serious injury associated with the reported device problem.No other patient or event details were provided.

• 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.; 741 boston post road; suite 201; guilford CT 06437
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 15986500
• MDR Text Key: 308234502
• Report Number: 3003521780-2022-00010
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020628
• UDI-Public: 10815098020628
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K141809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2022

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: 03/26/2021
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2020
• 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