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U.S. Department of Health and Human Services

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

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MEDISAFE UK LTD. NIAGARA SI ULTRASONIC; WASHER/DISINFECTOR Back to Search Results
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.
 
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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 Key13826726
MDR Text Key297516094
Report Number9617134-2022-00001
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
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
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
Initial Date Manufacturer Received 03/04/2022
Initial Date FDA Received03/19/2022
Supplement Dates Manufacturer Received03/04/2022
Supplement Dates FDA Received07/29/2022
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 Number1
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