MAUDE Adverse Event Report: RESPIRONICS, INC. PICO NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1104923
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of an allegation of a reaction (redness, blisters, swollen eye) to a user's face while using the pico nasal mask for 3 weeks.This was reported to the user's physician as an "infection" by his daughter, who stated she is a nurse.The physician prescribed two different antibiotics for the user based on the information from the daughter, without examining the user.There was no report of serious or permanent injury, and no medical intervention required other than the prescribed antibiotics.The user remains at home using a different mask.It is unknown when the redness and/or infection began.It is unknown if the user washed the mask prior to use, and regularly after use, as recommended by the manufacturer.Although the reported event does not meet criteria as a serious or permanent injury, the manufacturer is filing this report voluntarily due to the user being prescribed antibiotics to alleviate symptoms.The manufacturer has requested return of the mask for investigation.Upon completion of the manufacturer's investigation, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer has made numerous attempts to have the mask returned for investigation.No product has been received.This nasal mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.The mask is to be used on patients >66 lbs/30 kg, for whom cpap or bi-level therapy has been prescribed.The user is warned to discontinue use and contact a healthcare professional if skin redness, irritation, or discomfort is experienced.The user is further warned not to overtighten the headgear straps, and to watch for signs of overtightening such as excessive redness, sores, or bulging skin around the edges of the mask.Based on the information available, the manufacturer concludes no further action is necessary.The part number has been corrected to reflect the most accurate information.

• Brand Name: PICO NASAL MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge drive; murrysville PA 15668
• MDR Report Key: 8772504
• Report Number: 2518422-2019-01481
• Device Sequence Number: 19343818
• Product Code: BZD
• UDI-Device Identifier: 00606959037618
• UDI-Public: 00606959037618
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K121631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1104923
• Device Catalogue Number: 1104923
• Device Lot Number: 181016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Weight: 100