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	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the unit's software shows that the device operated for a total of 194 hours and 19,582 compressions.Beginning on (b)(6) 2017, the unit detected a problem with the home sensor and began warning the user by flashing the service light and beeping.There is no indication of any user interaction to address the unit's warning condition prior to its use on (b)(6) 2017.Analysis of the device by defibtech confirmed that the home sensor magnet became dislodged which was detected by the unit and reported on (b)(6) 2017.Based on the investigation, this mdr is being submitted for user error as the user failed to take action when the device detected a problem with the home sensor and began warning the user by flashing the service light and beeping on (b)(6) 2017.
Event or Problem Description
A fire department reported that they tried to use the rmu-1000 in a rescue attempt, but the unit's service light was flashing and beeping.No additional event or patient information was provided.

• 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: 6730247
• Report Number: 3003521780-2017-00013
• Device Sequence Number: 882373
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 00815098020539
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1