BIRD BLENDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-17 for BIRD BLENDER manufactured by 3m Bird Products Corporation.

Event Text Entries

[162] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 413
• MDR Report Key: 413
• Date Received: 1992-04-17
• Date of Report: 1992-04-08
• Date of Event: 1992-03-20
• Date Facility Aware: 1992-03-31
• Report Date: 1992-04-08
• Date Reported to FDA: 1992-04-08
• Date Reported to Mfgr: 1992-04-08
• Date Added to Maude: 1992-04-28
• 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: BIRD BLENDER
• Generic Name: OXYGEN BLENDER APPARATUS
• Product Code: JRO
• Date Received: 1992-04-17
• ID Number: ASSET NO. 12469
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 407
• Manufacturer: 3M BIRD PRODUCTS CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-04-17