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

Model Number	RMC-A1000
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported receiving this battery pack from a distributor.Records indicate the battery was originally shipped on june 12, 2023.According to the device user manual, a battery pack should not remain in ship mode for more than 12 months before being fully charged.In this case, it appears likely that the battery pack remained in ship mode for approximately 2 years, significantly exceeding the recommended storage duration and resulting in the battery pack's inability to power on the device.
Event or Problem Description
A customer reported their arm battery will not charge or power on.They reported that this battery pack has bever been used.They reported that this did not occur during patient use.

• Brand Name: LIFELINE
• Common Device Name: AUTOMATED 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 st.; branford CT
• Manufacturer Contact: nissa soto ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 22569529
• Report Number: 3003521780-2025-00749
• Device Sequence Number: 17142293
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: (01)10815098020536
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: RMC-A1000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2016
• 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