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

Model Number	RMU-1000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting of the arm with the customer revealed that the arm's battery packs had expired, with a labeled expiration date of 06/30/2020.The cause of the arm not powering on was related to a lack of maintenance.As a follow-up with the customer, the battery packs were replaced, and the proper maintenance of the device was reviewed.
Event or Problem Description
The customer reported that when responding to a patient involved in a car accident, the chest compressor would not power on or perform compressions.The customer stated that they tried to turn on the arm; it responded but could not lower the piston to the patient's chest.They attempted this a total of three times, but the arm shut off each time.It was reported that the patient did not survive.

• Brand Name: LIFELINE
• Common Device Name: COMPRESSOR, CARDIAC, EXTERNA
• 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: 20257384
• Report Number: 3003521780-2024-01035
• Device Sequence Number: 7934584
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P160032
• 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): 08/26/2024

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
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2018
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 68 KG