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

Model Number RMU-1000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Although requested, the electronic data from the device has not yet been returned.The investigation is on-going and no root cause is known.Should additional information become available, a follow-up mdr will be submitted.

Event Description

A professional customer reported that they deployed the device on female patient (date of the event was not provided), and after pausing the device to check the patient's vitals, the unit would not restart compressions and started flashing its warning light.They reported that they removed the device, performed manual compressions and were unsure of the patient's outcome.

• Brand Name: LIFELINE ARM
• Type of Device: CARDIAC COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• Manufacturer (Section G): DEFIBTECH, L.L.C.; 741 boston post road; suite 201; guilford CT 06437
• Manufacturer Contact: ed horton ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 7434096
• MDR Text Key: 105921667
• Report Number: 3003521780-2018-00006
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

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
• Device Operator: No Information
• Device Model Number: RMU-1000
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1