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

Model Number RMU-1000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Although requested, the customer reported that they decided to purchase a cpr device from another company and had traded the device in.Based on the lack of information provided, the root cause of the event could not be determined.Should additional information become available a follow-up mdr will be submitted.

Event Description

At 03:45 this morning, our ambulance was dispatched for a report of a (b)(6) year-old female down in the snow for an unknown amount of time and the patient was not breathing.Our crews arrived and the patient was found to be suffering from severe hypothermia and in cardiac arrest.The defibtech compression device was deployed, and the patient was treated and transported to the er.Our crew arrived at the er at 04:26, the patient was in persistent ventricular fibrillation and had been shocked several times.Care continued in the er and the er doctor requested that the defibtech be continued while the patient was warmed.The patient had a core temp of 72 degrees.The defibtech was connected to a power supply as the er staff continued care.Another hospital was contacted for possible transfer for echmo.At approximately 06:30 following a device pause for a rhythm check, the defibtech threw a wrench and ceased perfroming compressions.The er staff immediately switched to manual compressions.It was repored that the patient survived.

• 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: 11509552
• MDR Text Key: 257211342
• Report Number: 3003521780-2021-00005
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: (01)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: 02/16/2021

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
• Device Operator: Health Professional
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2017
• 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
• Patient Age: 54 YR