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

Model Number RMU-1000

Device Problem Mechanical Problem (1384)

Patient Problem Unspecified Heart Problem (4454)

Event Date 12/06/2023

Event Type  malfunction  

Event Description

A customer reported that during a rescue attempt on an 80-year-old patient in a nursing home, the device was powered on and began performing compressions on the patient before making a sound and ceasing compressions.It was reported the patient was not resuscitated.

Manufacturer Narrative

Although requested, the device associated with this complaint 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
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 18460245
• MDR Text Key: 332507767
• Report Number: 3003521780-2023-00247
• 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: 12/07/2023

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
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Sex: Male