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

Model Number	RMC-A1000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this complaint is underway and the root cause is not currently known.Should additional information become available a follow-up mdr shall be submitted.
Event or Problem Description
A customer reported an issue with the arm unit during a cardiac arrest rescue.They stated that the unit performed 2-3 compressions before stopping and triggering an alarm, despite the battery indicating a full charge.They attempted to troubleshoot the device but ultimately removed it and transitioned to manual cpr.After the rescue, the customer tested the unit, and it operated without issue.
Additional Manufacturer Narrative
The arm unit was returned for further evaluation and testing.Upon receipt, the device performed as expected and no functional failures were identified.Review of the event data indicated that, during the rescue, the arm detected that the piston required adjustment and generated a "piston not applied firmly to chest" warning to alert the user.This condition may occur when patient dynamics or physiology result in chest recoil that is significantly weaker or slower than typically expected.The condition may be further exacerbated when the patient interface pad is not adjusted to maintain firm contact with the patient's chest.

• Brand Name: LIFELINE
• Common Device Name: EXTERNAL 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 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 20763237
• Report Number: 3003521780-2024-01297
• Device Sequence Number: 9292055
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/23/2024

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: RMC-A1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown