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)
Date of Event	07/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electronic event record for automated chest compressor, serial number (b)(4), for (b)(6) 2017 is in two parts.The first part of the electronic record is thirty-six minutes long and contains a total of 3,210 compressions, followed by the second power on for fourteen minutes with a total of 1,556 compressions.The electronic data files show that during this rescue, the unit operated according to its specifications with no errors or device malfunctions noted.With regards to the unit not powering up after being paused, the electronic event record shows the cause is related to the user repeatedly pressing the power button for less than one second, causing the unit to show its battery status.As detailed in the device user manual, to power on the rmu-1000, the user must press the power button for more than a second.Due to the number of personnel who participated in this rescue, it is quite possible that once the patient was placed on the stretcher, the rescue was taken over by a professional who was not fully trained in the use of this device, causing the reported problem.Upon receipt of the returned automated chest compressor, serial number (b)(4), testing and evaluation of the device by our technicians showed that the device is operating properly and as designed - no device malfunctions were noted.
Event or Problem Description
It was reported that during a patient rescue by two paramedics and emts, the acc functioned normally for ten minutes until it was paused so that the patient could be moved onto a stretcher.When the operator attempted to resume compressions, the acc would not turn on.It was reported that the patient survived.

• 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: 6776345
• Report Number: 3003521780-2017-00014
• Device Sequence Number: 13485889
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 00815098020539
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K141809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2017

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: Paramedic
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1