DIATHERMY UNIT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-10 for DIATHERMY UNIT * manufactured by Mira Inc..

Event Text Entries

[4064459] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3594434
MDR Report Key3594434
Date Received2014-01-10
Date of Report2014-01-10
Date of Event2013-12-26
Report Date2014-01-10
Date Reported to FDA2014-01-10
Date Reported to Mfgr2014-01-28
Date Added to Maude2014-01-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameDIATHERMY UNIT
Generic NameDIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTI
Product CodeIMJ
Date Received2014-01-10
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMIRA INC.
Manufacturer Address414 QUAKER HWY UXBRIDGE MA 01569 US 01569

Device Sequence Number: 2

Brand NameDIATHERMY HANDPIECE
Generic NameCONTROLLER, FOOT, HANDPIECE AND CORD
Product CodeHQR
Date Received2014-01-10
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age1 DA
Device Sequence No2
Device Event Key0
ManufacturerMIRA INC.
Manufacturer Address414 QUAKER HWY UXBRIDGE MA 01569 US 01569

Patients

Patient NumberTreatmentOutcomeDate
10 2014-01-10
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