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

Model Number RMU-1000

Device Problem Failure to Run on Battery (1466)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 01/23/2021

Event Type  malfunction  

Manufacturer Narrative

Although requested, the device associated with this event has not been returned.The investigation is on-going and the cause for the event is not known.Should additional information become available a follow-up mdr shall be submitted.

Event Description

A professional customer reported that the chest compressor began beeping in the middle of a recuse and stopped compressions.They reported that they reset the device and it did the same thing a second time.The further reported that after the device stopped the second time, the patient regained circulation and survived.

Manufacturer Narrative

Review of the device's log files show the device recorded an error code (motor timeout) repeating shortly after arm use began.This error code typically is related to high friction within the ram.When the engine assembly was disassembled, the fit of the mid-housing into the outer housing was discovered to be very tight, and not easily moved.The motor timeout error was confirmed to have been attributed to tolerance stacking.

• Brand Name: LIFELINE
• Type of Device: CARDIAC COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• MDR Report Key: 11377720
• MDR Text Key: 249946774
• Report Number: 3003521780-2021-00003
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• Combination Product (y/n): N
• PMA/PMN Number: K141809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RMU-1000
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 125