BEAR 2 ADULT VOLUME VENTILATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-11 for BEAR 2 ADULT VOLUME VENTILATOR manufactured by Bear Medical Systems, Inc..

Event Text Entries

[6833] Patient with acute pulomary edema, pulmonary fibrosis. On ventilator w rate set at 50% o2. Vent began giving low pressure alarm w pt. Receiving o2 at 100%. Air compressor on ventilator turning on and off. Air pressure from wall outlet appear to be in working order. Pt. Assisted with ventilation until ventilator changed out. No adverse effects on patient. Biomed inhouse duplicated event 7/5. Field service engineer unable to duplicate on 7/8. In house air pressure checked, observed at 44. 4 psi. Psi increased to 52. 0 psi. Other devices in use on pt. Was iv infusion pump, feeding pum, cardiac monitor, dinamapp bp monitor, and pulse oximeter. Unable to determine cause. Ther ventilators in use at time without adverse events. Device not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-may-93. Service provided by: factory trained/authorized/owned service organization. Service records available. 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, mechanical tests performed. Results of evaluation: other. Conclusion: device evaluated and alleged failure could not be duplicated. 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: 8963
• MDR Report Key: 8963
• Date Received: 1993-08-11
• Date of Report: 1993-07-14
• Date of Event: 1993-07-04
• Date Facility Aware: 1993-07-04
• Report Date: 1993-07-14
• Date Reported to FDA: 1993-07-14
• Date Reported to Mfgr: 1993-07-05
• Date Added to Maude: 1994-11-02
• 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: BEAR 2 ADULT VOLUME VENTILATOR
• Product Code: BYT
• Date Received: 1993-08-11
• Model Number: BEAR 2
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-DEC-90
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8623
• Manufacturer: BEAR MEDICAL SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-11