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

Model Number	RMU-1000
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the initial report, we requested that the compression module be returned so that it may be investigated.To date, no items have been received.The investigation is currently ongoing and no root cause is known.Device not returned.
Event or Problem Description
A professional user reported that during transport of a female patient found unresponsive in the snow, the device stopped compressions and the unit indicated a problem.The professional users reported that they attempted to troubleshoot the device while it remained on the patient as opposed to removing it and performing manual chest compressions, which resulted in chest compressions being delayed for approximately one minute.After successfully troubleshooting the device, it began performing compressions.The professional user reported that the patient was in asystole from the beginning of the event and was not resuscitated.The professional user further reported that after the rescue, they operated the device on a cpr dummy without incident.
Additional Manufacturer Narrative
Analysis of the electronic event record for the reported rescue attempt on (b)(6) 2016 is as follows: the first part of the event record lasted 39 minutes with a total of 1,573 compressions and contained two instances where the unit stopped compressions to prompt the user to adjust the position of the piston and ends with the user powering off the unit.After 4 minutes, the user powered the unit back on, adjusted the piston and ran the unit for a total of 67 compressions.This second event record contained one instance where the unit stopped compressions to prompt the user to adjust the position of the piston and ends with the user powering off the unit.The user powered the unit back on, adjusted the piston, and ran the unit for a total of 95 compressions until powering the unit off.No additional event information was available.The compressions surrounding the unit prompting the user to adjust the piston show lots of variations in positioning, indicative of significant motion of patient and unit, most likely due to transportation.Additionally, testing and examination of the returned cardiac chest compressor and battery pack, which included visual, and functional testing did not identify any device malfunctions; the device and battery pack are functioning properly as designed.

• Brand Name: LIFELINE
• Common Device Name: EXTERNAL CARDIAC COMPRESSOR
• Manufacturer (Section D): DEFIBTECH L.L.C.; 741 boston post road; suite 201; guilford CT 06437
• MDR Report Key: 6298133
• Report Number: 3003521780-2017-00004
• Device Sequence Number: 310483
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 00815098020539
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2017

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: Emergency Medical Technician
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1