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

Model Number RMU-1000

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The electronic data from the device shows that the unit performed a total of 104,947 compressions and that on (b)(6) 2019 the device reported a home sensor warning.Evaluation of the device identified damaged internal parts which are resulting in the device's compression piston to jam.The investigation is currently on-going, and no root cause is currently known.Should additional information become available a follow-up mdr will be submitted.

Event Description

A customer (a fire department) reported that when they went to use the device in a rescue, the wrench/service light and warning light were on and the device would not perform compressions.They were not sure if there was a death or serious injury related to the event.

Manufacturer Narrative

The unit behaved properly on a rescue on (b)(6) 2019 during which it successfully delivered 2,825 compressions.The unit was powered off after the rescue on (b)(6) 2019 and was not powered on again until (b)(6) 2019.When it was powered on on the (b)(6) , the motor stalled and was unable to find home multiple times.This is indicative of mechanical damage, which is supported by our evaluation of the device.The unit was likely too damaged to move the motor.This is why it was unable to find home and give compressions.The normal / expected behavior of the successful rescue on the (b)(6) paired with the inability to move the motor from mechanical damage on the (b)(6) suggest that the arm had been mishandled and damaged (for example, dropped) sometime between the (b)(6).The arm did not have any performance issues that self-inflicted this damage.

• 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: 8745432
• MDR Text Key: 214100659
• Report Number: 3003521780-2019-00013
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 00815098020539
• 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
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1