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

Model Number	RMU-1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the arm giving an audible alarm and red service indicator light.The compression piston will also not lower.The customer did not report this event occurred during patient use.
Additional Manufacturer Narrative
The customer reported that the arm acc was giving an audible alarm and red service indicator light.The compression piston will also not lower.The issue was discovered during routine equipment check and not during patient use.The maintenance schedule is not reported.No additional information is available at this time to further investigate the event.Always store the acc so it is ready to go for use.Store the compression module with a fully charged battery pack installed and a patient interface pad attached to the piston.It is recommended to maintain a charged spare battery pack and always have the external power adapter available with the unit.Although the rmu acc is designed for a wide variety of field use conditions, rough handling beyond specifications may result in damage to the unit should additional information become available a follow-up mdr shall be submitted.

• Brand Name: LIFELINE
• Common Device Name: EXTERNAL CARDIAC COMPRESSSOR
• 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 st.; branford CT 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 20148323
• Report Number: 3003521780-2024-00949
• Device Sequence Number: 4248886
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: RMU-1000
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown