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 No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Although requested, the device associated with the report has not yet be returned.The investigation is ongoing and a root cause is not currently known.Should additional information become available a follow-up mdr will be submitted.

Event Description

A fire department reported that their chest compressor stopped compressions during a rescue attempt.It was also reported that the patient was not resuscitated.No additional event or device information was provided.Although requested, the device associated with this event has not been returned and the cause for the event is not known.It is not known if the device was removed and if manual compression could be performed; therefore, this mdr is being submitted out of an abundance of caution.

Manufacturer Narrative

Analysis of the device identified that the rmu-1000's top screw became loose causing the reported device problems.Although the top screw came loose, this incident does not appear to be a production issue as the device's motor screw was torqued and a loctite patch was cured as required by the manufacturing process specification - mps.

• Brand Name: LIFELINE
• Type of Device: CARDIAC COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford, ct
• MDR Report Key: 10286057
• MDR Text Key: 232049461
• Report Number: 3003521780-2020-00006
• Device Sequence Number: 1
• Product Code: DRM
• 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: 06/17/2020

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: No Information
• Device Model Number: RMU-1000
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability