MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; NEBULIZER

Catalog Number HCS60004BL

Device Problem Failure to Power Up (1476)

Patient Problem No Code Available (3191)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

End-user stated she plugged in her nebulizer, heard a "small humming noise" and then the nebulizer stopped working.End-user attempted to turn on nebulizer multiple times but the machine would not turn on.End-user then called emergency medical services and was transported to a local emergency room where she received an albuterol/ipratropium nebulizer.End-users condition improved after the breathing treatments and was discharged home.We have not confirmed the complaint.Sample was not returned for investigation and a root cause cannot be determined.In an abundance of caution this medwatch is being filed.Device not returned.

Event Description

Nebulizer did not turn and required end-user to seek medical treatment.

• Type of Device: NEBULIZER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• Manufacturer Contact: megan debus ; one medline place; mundelein, IL 60060 ; 8477703962
• MDR Report Key: 6170775
• MDR Text Key: 62673844
• Report Number: 1417592-2016-00122
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: HCS60004BL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other