15 METER FLOWMETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-19 for 15 METER FLOWMETER manufactured by Oxequip - Allied Healthcare Products, Inc..

Event Text Entries

[899] The patient was desaturating while on ventilator and required manual ventilation. An ambu bag was connected toa flowmeter on the bed. Medical personnel visualized flowmeter and identified a flow of 5 liters per minute via the ball height in the flowmeter. After bagging the patient for approximately one minute without increasing oxygen saturation, it was identified that there ws no flow of 02 to the bag. The flowmeter was stuck at the 5 liters per minute mark. Oxygen tubing was attached to another flowmeter. Oxygen tubing was attached to another flowmeter. The patient required manual vent for approximately five minutesinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. 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. Results of evaluation: incorrect technique/procedure. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: user education provided. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3035
• MDR Report Key: 3035
• Date Received: 1992-08-19
• Date of Report: 1992-03-12
• Date of Event: 1992-02-27
• Date Facility Aware: 1992-02-27
• Report Date: 1992-03-12
• Date Added to Maude: 1993-04-05
• 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: 15 METER FLOWMETER
• Product Code: ETL
• Date Received: 1992-08-19
• ID Number: 34-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 2838
• Manufacturer: OXEQUIP - ALLIED HEALTHCARE PRODUCTS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-08-19