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

Model Number	RMU-1000
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/11/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CARDIAC COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• MDR Report Key: 10823935
• Report Number: 3003521780-2020-00008
• Device Sequence Number: 11570650
• Product Code: DRM
• UDI-Device Identifier: 00815098020539
• UDI-Public: 00815098020539
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: RMU-1000
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Weight: 127