MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE VENTED AUTOFEED CHAMBER; HUMIDIFER, CHAMBER

Catalog Number MR290

Device Problem Melted (1385)

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

Event Date 12/27/2014

Event Type  malfunction  

Event Description

While checking the patient's trach mask set-up i noticed her humidifier chamber was partially melted.Upon arrival the trach mask was set at 12l, and the humidifier was on "non-invasive" reading approximately 29 degrees.The patient was not wearing the mask, and per the patient's mom, she had not been for some time as she is getting used to her speaking valve during the day.

• Brand Name: VENTED AUTOFEED CHAMBER
• Type of Device: HUMIDIFER, CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE; 15365 barranca pkwy; irvine CA 92618
• MDR Report Key: 5388023
• MDR Text Key: 36753484
• Report Number: 5388023
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: MR290
• Device Lot Number: 1110060050DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1