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

Model Number	RMU-1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3003521780-2022-00010
• Device Sequence Number: 6209241
• Product Code: DRM
• UDI-Device Identifier: 10815098020628
• UDI-Public: 10815098020628
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K141809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown