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

Model Number RMU-1000

Device Problem Break (1069)

Patient Problem Unspecified Heart Problem (4454)

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

Although requested, the device associated with the event has not been returned and the cause of the complaint is not known.Should additional information become available a follow-up mdr shall be submitted.

Event Description

A customer reported the arm's housing cracked during a rescue attempt.They further reported that the cracked housing did not affect the outcome of the rescue.No patient information was provided other than the patient survived to hospital but did not survive to hospital discharge.

• Brand Name: LIFELINE
• Type of Device: AUTOMATED CHEST 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: 18918500
• MDR Text Key: 337849696
• Report Number: 3003521780-2024-00169
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

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 Operator: Health Professional
• Device Model Number: RMU-1000
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1