MAUDE Adverse Event Report: POWER CONTROL; MOTOR CONTROL UNIT 2303

Model Number 2303011

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility and manufacturer will be contacted for additional information.Upon receipt of new information, a follow-up report will be submitted,.

Event Description

It was report to rw mic that the power control unit i (rw mic clinical specialist) have here at the house did the same thing the other day.So i was taking a video of this to show you guys what it was doing.I will send you the video.On the video you will notice a brown speck above the footswitch symbol.That speck was inside the unit heating up but i did not even notice the spot until after my hand touched it and it was real hot.It then lit up and almost caught on fire.Also reported at the same time by the clinical specialist, the piranha power control unit (loaner #1 unit that vanderbilt is sending back) had issues with the control unit freezing up.When i would unplug the communication cable to adjust the blade, the tool would appear but not the double arrow button.I had to turn the unit off and back on to get the arrow button to pop back up.This incident will be filed under mdr report 1418479-2020-00023.

Event Description

The purpose of this submission is to report the results of the device investigation.According to investigation report - device evaluation: device evaluation was conducted using visual, functional, mechanical and electrical testing.The housing of the device was so badly bent that it had to be straightened first to get the housing of the device open.Short circuit in the membrane keyboard, burn hole in the front membrane.There are images available.The reported condition was confirmed.As for product disposition, that needs to be clarified with the customer.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr closed.Rwmic will submit a follow up report if/when new information becomes available.

• Brand Name: POWER CONTROL
• Type of Device: MOTOR CONTROL UNIT 2303
• MDR Report Key: 10538490
• MDR Text Key: 218269132
• Report Number: 1418479-2020-00025
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (y/n): Y
• PMA/PMN Number: K030082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2014
• 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
• Treatment: SUCTION PUMP: P/N: 2208011, S/N (B)(6)