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

Model Number	RMU-1000
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, neither the electronic data files from the device, nor any patient or event information has been provided.The investigation remains open, and no root cause is known.Should additional information become available, a follow-up mdr will be submitted.
Event or Problem Description
It was reported by a professional user that the device had its service and warning indicators lit during use.It was also reported that although the patient in this case was not resuscitated, the patient's outcome was not related to the reported device problem.No other patient or event details were provided.
Additional Manufacturer Narrative
Received unit with the lower ball screw cap screw and washer loose inside of the compression module.Cap screw was verified as being the current version screw with thread lock.Reassembled unit and ran test compressions in test fixture with no errors.Root cause traced to component failure of cap screw.

• 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: 6980762
• Report Number: 3003521780-2017-00019
• Device Sequence Number: 444695
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 0100815098020539
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K141809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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 the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1