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

Model Number	RMU-1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CARDIAC COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• MDR Report Key: 8745432
• Report Number: 3003521780-2019-00013
• Device Sequence Number: 19403283
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 00815098020539
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1