MAUDE Adverse Event Report: MEDISAFE UK LTD. MEDISAFE SONIC IRRIGATOR PCF; DISINFECTOR

Device Problem Smoking (1585)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the thermostat was not operating properly allowing the unit to overheat resulting the reported event.The unit was manufactured in 2010 making it approximately 10 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities.The medisafe sonic irrigator pcf operator manual states (p43), "medisafe recommends that your si pcf be serviced in accordance with the schedule contained within the si pcf service manual, at intervals of 3 months.Note: service and repair should be referred to qualified persons only." the technician replaced the thermostat and made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.The technician counseled user facility personnel on proper preventive maintenance activities for their medisafe sonic irrigator pcf.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that their medisafe sonic irrigator pcf was emitting smoke.The smoke alarm was activated; no evacuations were conducted.The employee who identified the smoke immediately turned off the unit.No report of injury.

• Brand Name: MEDISAFE SONIC IRRIGATOR PCF
• Type of Device: DISINFECTOR
• Manufacturer (Section D): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishop stortford; hertforshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer (Section G): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishop stortford; hertforshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 10217822
• MDR Text Key: 197826932
• Report Number: 9617134-2020-00002
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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: 06/01/2020
• 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