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

Model Number RMU-1000

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis of the data from (b)(6)2021 shows that the user powers the unit on, adjusts the device, and runs continuous compressions.The user makes a few pauses, adjust, and re-run cycles.A total of 908 compressions are completed.The device then experiences a piston adjust error, the user clears and tries to re-run compressions, the device experiences a stroke depth not within specs error, the user power cycles.Upon defibtech service receipt of the device, it was found that the motor connector was damaged.This was confirmed by measuring the resistance across the motor connector pins, one of which was open / disconnected (pin corresponding to black wire).The root cause of this complaint is the failed motor connector pin (corresponding to black wire).

Event Description

It was reported by a professional user that after twenty minutes of use, the rmu-1000 stopped, and after replacing the battery, the device was removed and replaced with another compression module on the frame that was in use.It was reported that the patient was not resuscitated.

• 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: 13652656
• MDR Text Key: 289184362
• Report Number: 3003521780-2022-00003
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2020
• 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): Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 109 KG