MAUDE Adverse Event Report: SALTER LABS SALTER LABS BUBBLE HUMIDIFIER

Model Number 7600

Device Problem Device Reprocessing Problem (1091)

Patient Problem Respiratory Tract Infection (2420)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

Initial and final report.Device not provided.

Event Description

Initial and final report: distributor reported that the patient was using the same salter labs humidifier bottle for over 1 year.It developed buildup that was reported to be mildew.The patient reports developing a lung infection and was treated with antibiotics and recovered.No other injury reported.

• Brand Name: SALTER LABS BUBBLE HUMIDIFIER
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• Manufacturer (Section G): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• Manufacturer Contact: mara caler ; 2365 camino vida roble; carlsbad, CA 92011 ; 7607957094
• MDR Report Key: 6004718
• MDR Text Key: 56766476
• Report Number: 3000219639-2016-00007
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7600
• Device Catalogue Number: 7600
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other