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

Model Number	RMC-A1000
Medical Device Problem Codes	Mechanical Problem (1384); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a cardiac arrest, the device malfunctioned during transport and was not able to be restarted and the device was beeping and flashing.They also reported that rattling can be heard from inside the compression module.They reported that the patient was not resuscitated.
Additional Manufacturer Narrative
Although requested, additional information regarding the complaint has not been provided and the cause of the complaint is not known.Should additional information become available, a follow-up mdr shall be submitted.

• 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 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 20847025
• Report Number: 3003521780-2024-01355
• Device Sequence Number: 8100328
• Product Code: DRM
• UDI-Device Identifier: 10815098020628
• UDI-Public: (01)10815098020628
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RMC-A1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Hispanic
• Patient Race: White