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

Model Number	1104916
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was made aware of an allegation by an end user that he developed an allergic reaction while using a pico nasal mask.The user was reportedly prescribed a type of topical cream.The manufacturer received the mask for investigation.There were no defects noted.The certificate of conformance confirmed the mask was manufactured to specifications.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 (>66lbs/30kg) for whom cpap or bi-level therapy has been prescribed.Labeling warns that "some users may experience skin redness, irritation, or discomfort.If this happens, discontinue use and contact your healthcare professional." this mask meets all relevant standards for biocompatibility.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: PICO NASAL MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 12638353
• Report Number: 2518422-2021-05369
• Device Sequence Number: 19159791
• Product Code: BZD
• UDI-Device Identifier: 00606959035867
• UDI-Public: 00606959035867
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K110405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: 1104916
• Device Catalogue Number: 1104916
• Device Lot Number: 201204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/15/2021
• 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: 65 YR