MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. B&F NEBULIZER

Model Number 64085

Device Problem No Pressure (2994)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

The problem of the supply tube coming off the nebulizer is related to the supply tube being exposed to excessive flow rates.Our "bebulizers" are designed to use a flow rate of 5 to 11 liters per minute.Flow rates above 11 liters per minute can cause a pressure build up that potentially allows the tube to expand and come off the nebulizer.We do not know the flow rate the emts were attempting to use when the tube disconnected.Our nebulizer compressors produce 5 to 11 liters per minute floe.Therefore, we are not concerned when used with the proper medical device.We checked our complaint files for the last five (5) years and found no other complaints against this nebulizer.Our disposable nebulizers are sold at a rate of over one thousand units per month.We will review the labeling to see if any additional information needs to be added.

Event Description

It was reported oxygen tubing would not stay connected to nebulizer under pressure.The fitting at the end of the tubing did not appear to fit the nebulizer correctly.The tubing repeatedly popped off during patient care.The emt in charge had to tape the tubing in place.The poor fitting was verified by other emts.

• Brand Name: B&F NEBULIZER
• Type of Device: NEBULIZER
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave.; st. louis MO 63110
• Manufacturer Contact: jon stillman ; 1720 sublette ave.; st. louis, MO 63110 ; 3142681616
• MDR Report Key: 8189992
• MDR Text Key: 131341946
• Report Number: 1924066-2018-00006
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 64085
• Device Catalogue Number: 64085
• Device Lot Number: 0714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other