MAUDE Adverse Event Report: MEDISAFE UK LTD. NIAGARA SI ULTRASONIC; WASHER/DISINFECTOR

Device Problems Fire (1245); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that their niagara si ultrasonic caught fire.No report of injury.

Manufacturer Narrative

Steris dealer, medon scandinavia inspected the unit and observed damage to the thermostat and heater.The root cause of the damage could not be determined.The unit was shipped in 2014 making it approximately 8 years old at the time of the reported event.This unit is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.Due to the damage, the customer will be provided with a replacement unit.A 2-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: NIAGARA SI ULTRASONIC
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer (Section G): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 13826726
• MDR Text Key: 297516094
• Report Number: 9617134-2022-00001
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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