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 11/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by an ems department that when they arrived on scene and powered on the compression module, its service and warning lights were on and it would not perform compressions.They turned it off then back on with the same result.Cpr was performed manually, and the patient never responded.No additional event or patient information was provided.Although there was no connection reported between the device malfunction and the outcome of the patient, as manual compressions were performed, this mdr is being submitted out of an abundance of caution.

Manufacturer Narrative

Analysis of the returned device identified the root cause as being related to an open trace on the arm power motor drive pcb which caused the battery (rbp-g100gg) to drain approximately twice as fast.

Manufacturer Narrative

Analysis of the returned device identified the root cause as being related to a component failure on the arm power board pcb, specifically the power controller chip.

• 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: 10991543
• MDR Text Key: 241096121
• Report Number: 3003521780-2020-00010
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• 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,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• 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?: Yes
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death