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

Model Number RMU-1000

Device Problem Failure to Run on Battery (1466)

Patient Problem Death (1802)

Event Date 10/11/2020

Event Type  malfunction  

Manufacturer Narrative

Although requested, the device associated with this event has not been returned, and the cause for the event is not known.Should additional information become available, a follow-up mdr will be submitted.

Event Description

An emergency medical transportation company reported that their chest compressor stopped compressions during a rescue attempt, and that both the service and warning lights were lit.It was also reported that the patient was not resuscitated, and no additional event or device information was provided.It is not known if the device was removed and if manual compression were performed; therefore, this mdr is being submitted out of an abundance of caution.Although requested, the device associated with this event has not been returned and the cause for the event is not known.

Manufacturer Narrative

Evaluation and testing of the returned chest compressor identified extensive internal rust, thick residue, debris and viscus fluids as well as mechanical damage in the device consistent with the software evaluation which shows numerous motor errors such as: "driver faulted at power up" and "motor did not move in time".

• Brand Name: LIFELINE
• Type of Device: CARDIAC COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• MDR Report Key: 10823935
• MDR Text Key: 219545374
• Report Number: 3003521780-2020-00008
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 00815098020539
• Combination Product (y/n): N
• PMA/PMN Number: K141809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RMU-1000
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 127