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MAUDE Adverse Event Report

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3M BIRD PRODUCTS CORPORATION BIRD BLENDER OXYGEN BLENDER APPARATUS   Back to Search Results
Event Date 03/20/1992
Event Type  Malfunction   Patient Outcome  Other;
Event Description

About one hour after admission to nbicu, the patient became bradycardic and patency of airway was suspect. The staff rn attempted to bring the patient's heart rate and 02 saturations back up by hand bagging the patient with manual resuscitator connected to the oxygen blender apparatus supposedlyy delivering 100% oxygen. The patient's condition did not improve. A staff member then found that the high pressure oxygen line was disconnected fromrthe wall. The alarm on the blender should have sounded as a result of the high pressure line not being connected to the wall. The patient was receiving 21% oxygen rather than 100% oxygen for 10-15 minutes. After discovery of the disconnected oxygen line, the patient's oxygen was immediately reconnected and the patient's condition improved. Following the incident the patient was scheduled for a cranial ultrasound. The ultrasound results showed no signs of bleeding. To date, the effects from patient not receiving 100% oxygen are unknown. The oxygen blender device was taken to a third party for evaluation. The report from the evaluation stated that there was no audible alarm for a disconnected air hose or a disconnected oxygen hose. The device was not disembled during the evaluation. To date, the device has not been repaired. 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-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: other, alarm failure. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, user education provided, invalid data. Invalid data - on device destroyed/disposed of status.

 
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Brand NameBIRD BLENDER
Type of DeviceOXYGEN BLENDER APPARATUS
Manufacturer (Section D)
3M BIRD PRODUCTS CORPORATION
Device Event Key407
MDR Report Key413
Event Key350
Report Number413
Device Sequence Number1
Product CodeJRO
Report Source User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/08/1992
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/1992
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
OTHER Device ID NumberASSET NO. 12469
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/08/1992
Distributor Facility Aware Date03/31/1992
Event Location Hospital
Date Report TO Manufacturer04/08/1992
Is the Device an Implant? No

 
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