VARIES BIOFEEDBACK SYSTEM MH330, I330

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-10 for VARIES BIOFEEDBACK SYSTEM MH330, I330 manufactured by J And J Engineering, Inc..

Event Text Entries

[16764739] Bio feedback system has excess current leakage. On 9/3/93 an electrical safety inspection was performed. The computer was discovered to have leakage current measured at 400 microamps on the monitor section, and 130 microamps measured on the computer. The leakage current is cumulative which means the total system has had in excess of 600 microamps total leakage. As the most liberal codes allow a total of only 300 microamps total leakage, this system cannot be considered safe for hosp use with pts. The regulations referenced to for leakage current limits is for this purpose the nfpa 99 life safety code, chapter 7. From the time of inspection to present, biomed tech has spent a very considerable amount of time contacting mfr in an attempt to resolve this problem. They informed biomed tech they could not come up with a solution, and would let their testing dept handle this problem. When no solution was forthcoming, biomed tech made many attempts to contact co again with no success. Biomed tech was informed that svc mgr wuold send another monitor assembly in order to see if it might help the leakage current problem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1000062
• MDR Report Key: 10507
• Date Received: 1993-12-10
• Date of Report: 1993-11-26
• Date of Event: 1993-10-23
• Date Added to Maude: 1993-12-16
• Event Key: 0
• Report Source Code: Voluntary 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: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VARIES BIOFEEDBACK SYSTEM
• Product Code: IOA
• Date Received: 1993-12-10
• Model Number: MH330, I330
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 10507
• Manufacturer: J AND J ENGINEERING, INC.
• Manufacturer Address: POULSBO WA 98370 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-12-10