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

Model Number RMU-1000

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

Although requested, neither the electronic data files from the device nor any additional patient or event information has been provided.The investigation remains open, and no root cause is known.Should additional information become available, a follow-up mdr will be submitted.

Event Description

On (b)(6) 2017 a distributor reported their customer could not use the device as its battery was depleted, even though they charge the battery periodically.It was reported that this did not result in death or serious injury to the patient.No additional event or patient information was available.

Manufacturer Narrative

The electronic data files from rmu-1000 serial number (b)(4) show the device had delivered a total of 21,270 compressions.Battery pack serial number (b)(4) was inserted into the unit on 3-1-17 and charged to 93% capacity.The unit sat until 5-10-17 when it was deployed for the presumed rescue attempt with battery pack serial (b)(4) which had discharged to 8% capacity at this point.The electronic data files shows multiple instances where the power button was repeatedly pressed for less than 1 second, which by design, shows the battery pack charge status.The user then inserted battery pack serial number (b)(4) (at 94% capacity) and continued the rescue where the device delivered a total of 1,751 compressions over the 45 minute rescue.During the entirety of this event, the device operated as designed - the compression parameters remained excellent, well within their tolerances.In this case it appears that the user failed to follow the manufacturer's instructions as to the proper maintenance and operation of this device, specifically; the user did not maintain the battery pack per the manufacturer's instructions and did not follow the manufacturer's instructions as to the steps required to power on the unit.

• 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: ed horton ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 6631159
• MDR Text Key: 77407552
• Report Number: 3003521780-2017-00011
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RMU-1000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other