TR3000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for TR3000 manufactured by Mira.

Event Text Entries

[16478780] Diathermy unit failed-circuitry failure at jack. Cork and tip were changed two times, but unit continued to fail. Clinical engineering found and repaired a broken wire on the output cableinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jan-92. Service provided by: user facility biomedical/bioengineering department. Service records available. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination. Results of evaluation: other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4723
• MDR Report Key: 4723
• Date Received: 1992-07-31
• Date of Report: 1992-05-12
• Date of Event: 1992-04-23
• Date Facility Aware: 1992-04-23
• Report Date: 1992-05-12
• Date Reported to Mfgr: 1992-05-12
• Date Added to Maude: 1993-06-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: DIATHERMY
• Product Code: IMJ
• Date Received: 1992-07-31
• Model Number: TR3000
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4439
• Manufacturer: MIRA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-31