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

Model Number RMU-1000

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

A customer reported an event rescue with an rmu-1000 where after running compressions for about 30 minutes, the device started alerting.They reported that they removed the device and resumed manual compressions.They also reported that the patient did not survive to the hospital.

Manufacturer Narrative

Although requested, the device 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.

• 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: 19140208
• MDR Text Key: 340582497
• Report Number: 3003521780-2024-00334
• Device Sequence Number: 1
• Product Code: DRM
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RMU-1000
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Sex: Male