MAUDE Adverse Event Report: MIRA INC. DIATHERMY UNIT; DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTI

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2013

Event Type  malfunction  

Event Description

Plugged in diathermy unit and turned on.Red light indicated machine was on.When handpiece was activated, white light did not turn on and there was no buzzing sound as there should be.Surgeon concluded unit was not working.Used standard bipolar cautery instead which is not as precise in the lower settings.No patient harm.

• Brand Name: DIATHERMY UNIT
• Type of Device: DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTI
• Manufacturer (Section D): MIRA INC.; 414 quaker hwy; uxbridge MA 01569
• MDR Report Key: 3594434
• MDR Text Key: 4064459
• Report Number: 3594434
• Device Sequence Number: 1
• Product Code: IMJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/10/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/28/2014
• Patient Sequence Number: 1
• Patient Age: 54 YR