BEAR 3 BV 581

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-01 for BEAR 3 BV 581 manufactured by Bear Medical.

Event Text Entries

[5359] Device in use & operating correctly. Staff reported exhaled tidal volumes in excess of set volumes. Vent removed from service. Vent tested 7/11/94, tidal volumes 50% above switch setting. Peak flows measured at 30% - 75% above switch setting. Replaced defective purge valve. Performed calibration tests to verify correct operation. Ran vent 24 hrs. To burn-in. Full operational verification. Returned to service 7/14/94. Device not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-may-94. Service provided by: independent factory trained/authorized service organization. Service records available. Invalid data - regarding whether event presents imminent hazard. 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, other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. 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: 9668
• MDR Report Key: 9668
• Date Received: 1994-08-01
• Date Added to Maude: 1995-01-13
• 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: ADULT VENTILATOR
• Product Code: BYT
• Date Received: 1994-08-01
• Model Number: BEAR 3
• Catalog Number: BV 581
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 9320
• Manufacturer: BEAR MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-08-01