MAUDE Adverse Event Report: RESMED AIR FIT F10 FULL FACE MASK

Model Number 63130

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Bacterial Infection (1735)

Event Date 06/06/2016

Event Type  malfunction  

Event Description

The patient wore an air fit medium mask from resmed.We have two different lot numbers for that model and size.I sent one of each to microbiology.One came back no growth after four days, but the other one (lot #1143645) came back growth of sphinomonas paucimobilis (pseudomonas paucimobilis).I have removed the remaining air fit medium masks with that lot number.This was a voluntary test of the medical device and was found to have growth of sphingomonas paucimobilis (pseudomonas paucimobifis) on the product.

• Brand Name: AIR FIT F10 FULL FACE MASK
• Type of Device: AIR FIT F10 FULL FACE MASK
• Manufacturer (Section D): RESMED
• MDR Report Key: 5719861
• MDR Text Key: 47228110
• Report Number: MW5062766
• Device Sequence Number: 1
• Product Code: BZD
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 63130
• Device Lot Number: 1143645
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2016
• Type of Device Usage: N
• Patient Sequence Number: 1