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

Model Number RMU-1000

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

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

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device's electronic history showed a total of 15,579 compressions.The event in question, which occurred on (b)(6) 2017, had a total of 1,988 compressions.According to the device's electronic history, compressions stopped 30 minutes into the event when the unit noted an error, "motor didn't move in time" and elevated temperatures.The device was examined by defibtech and the unit's piston was noted as manually extending and retracting smoothly but making noise.Compressions were performed with no observations noted.The unit was opened and visually inspected.The visual inspection determined that the cause of the event was related to the device's ball screw assembly not being lubricated in manufacturing as required.

Event Description

On may 11, 2017 a distributor reported their customer recently put their chest compressor unit into use.They had two uses the prior week and raved about its performance after the first use.During the second use, on a patient who collapsed in a bathroom (no indication of how long they had been down), the unit performed flawlessly for about 20 minutes.As they were placing the patient in a vehicle, the device's warning indicators came on and the piston stopped in the down position.They immediately made sure that the device hadn't shifted and was properly placed on the patient's chest.They checked the battery which indicated greater than 50% remaining and noted that the compression module was hot to the touch.They removed the device and performed manual compressions.The patient outcome was not provided.

• Brand Name: LIFELINE
• Type of Device: AUTOMATED CHEST 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: ed horton ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 6609417
• MDR Text Key: 76720545
• Report Number: 3003521780-2017-00010
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RMU-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other