BARD 3000 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-09 for BARD 3000 N/A manufactured by Birtcher Medical Systems, Inc..

Event Text Entries

[2729] Bard 3000 being used during case for cautery purpose. Patient was properly grounded. Bard setting @30 cutting and 30 coagulation. Cutting not working @ setting so increased at doctors request with no result. Bard modes changed per doctor request. While using bard after several attempts and changes doctor felt there was an electrical surge. Bard 3000 replaced with birtcher 4400. Minor patinet injury-partial transection of right greater cervicle nerve due to surge, as stated by doctor involved in case. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-nov-91. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: telemetry failure, unanticipated short term complication of procedure, invalid data. Conclusion: device evaluated and alleged failure could not be duplicated, no failure detected and product within specification. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4186
• MDR Report Key: 4186
• Date Received: 1992-07-09
• Date of Report: 1992-05-15
• Date of Event: 1992-04-28
• Date Facility Aware: 1992-05-04
• Report Date: 1992-05-15
• Date Added to Maude: 1993-05-17
• 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

• Brand Name: BARD
• Generic Name: ESU ELECTROSURGICAL UNIT
• Product Code: FAR
• Date Received: 1992-07-09
• Model Number: 3000
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: C01418
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-APR-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3919
• Manufacturer: BIRTCHER MEDICAL SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-09