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

Model Number RMU-1000

Device Problem Complete Loss of Power (4015)

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

Event Type  malfunction  

Manufacturer Narrative

Defibtech is attempting to attain a copy of the electronic data from the device.To date, however, the electronic data has not been received.The investigation is currently on-going, and no root cause is known.Should additional information become available, a follow-up mdr will be submitted.

Event Description

An ambulance company reported that the battery stopped working in the device during a rescue however a spare battery was used, and they were able to continue the rescue.It was not known if there was a death or serious injury associated with the event and no additional event or patient details were provided.

• 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: 8511371
• MDR Text Key: 150281973
• Report Number: 3003521780-2019-00008
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 00815098020539
• 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: 03/19/2019

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
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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