MAUDE Adverse Event Report: LIFELINE; AUTOMATED CHEST COMPRESSOR

Model Number RMU-1000

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

A customer reported that when the rmu-1000 was turned on, there was an alarm light a warning sound and would not function.They reported that this did not occur during patient use.

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
• MDR Report Key: 18717621
• MDR Text Key: 335554164
• Report Number: 3003521780-2024-00035
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K141809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RMU-1000
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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