MAUDE Adverse Event Report: MEDLINE; NEBULIZER

Model Number HCS4483

Device Problem Output below Specifications (3004)

Patient Problem No Code Available (3191)

Event Date 04/16/2015

Event Type  Injury  

Event Description

Nebulizer, decreased output, probable wrong particle size, deposition diminished.Start date: (b)(6) 2015.

• Type of Device: NEBULIZER
• Manufacturer (Section D): MEDLINE; mundelien IL 60060
• MDR Report Key: 4730561
• MDR Text Key: 5703838
• Report Number: MW5042311
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HCS4483
• Device Lot Number: 10062014N57
• Other Device ID Number: (01) 10080196715541
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 45