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 Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis of the returned device identified a greenish/black foreign residue on the inside of the device.It appears that at some point this liquid ran freely inside and throughout the device resulting in electrical and mechanical malfunctions.The greenish/black foreign residue appears to be a cleaning agent (like (b)(6)) that was used on the device and got into the compression module resulting in the observed device problems and the reason for this mdr.On october 9, 2019, we reached out to the customer to inquire about their cleaning procedures and to review the findings our investigation; specifically, the residue found in the arm compression module.We spoke with (b)(6) who confirmed they use (b)(6) which is green industrial degreaser to clean the arm after an event.We advised him of the cleaning requirements of this device as specified in the device labeling.Later that afternoon, we received a follow-up call from (b)(6), from the same company, who stated, contrary to what was reported by (b)(6), that they clean the arm with (b)(6) disinfectant wipes & (b)(6).

Event Description

It was reported by a professional user that a rescue team went to use the device during a rescue and after performing a couple of compression cycles, the device stopped performing compressions and the warning indicator and warning light went on.The rescue team stopped the device, repositioned it on the patient, restarted the device and after the device stopped a second time, the rescue team removed the device from the patient and provided manual cpr to the patient who survived.No additional patient or event information was provided.

• Brand Name: LIFELINE
• 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: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 9181246
• MDR Text Key: 208566852
• Report Number: 3003521780-2019-00018
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2017
• 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