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

Model Number RMU-1000

Device Problem Mechanical Problem (1384)

Patient Problem Cardiac Arrest (1762)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

A professional user reported they attempted to use the rmu-1000 to perform compressions on a patient, but the device had a warning light and when they retracted the device's piston, the ram cap and patient interface pad fell off.They reported they were unable to re-attach them and removed the device to begin manual cpr.Although it was reported that the patient did not survive to hospital, the patient death was not attributed to the use of the device and therefore this mdr is not identified as an adverse event.

Manufacturer Narrative

Although requested, the device associated with the complaint has not been returned and the cause of the event is not known.Should additional information become available, an updated mdr will be submitted.

• 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.; 14 commercial dr.; branford CT 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06511 ; 2034536654
• MDR Report Key: 17277718
• MDR Text Key: 319191917
• Report Number: 3003521780-2023-00017
• Device Sequence Number: 1
• Product Code: DRM
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RMU-1000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2018
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 95 KG