MAUDE Adverse Event Report: RESPIRONICS, INC. S CMFRTGEL BLUE NSL MSK W/HGR JPN; CPAP/BIPAP NASAL MASK

Model Number	1079091
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Abrasion (1689); Pressure Sore/Ulcer (2326)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information that the comfort gel blue s mask left scratches on the ala of his nose when he started to use a new mask in (b)(6).The patient saw a dermatologist, and the doctor diagnosed the scratches as pressure wounds.This was assessed as a serious injury.The customer has not yet recovered from the symptoms and submitted a photo of the injuries.Additional information has been requested regarding the details of the reported serious injury.The user manual states, ¿the headgear should fit comfortably, and the mask should not dig into your skin.If your skin bulges around the mask or if you see red marks on your face due to tightness, loosen the headgear.¿ philips is currently investigating this complaint.The device examination has not begun because the device has not yet been returned to the manufacturer for investigation.As part of the complaint handling process, the manufacturer will attempt to retrieve the device for investigation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
The manufacturer received information that the comfort gel blue s mask left scratches on the ala of his nose when he started to use a new mask in june.The patient saw a dermatologist, and the doctor diagnosed the scratches as pressure wounds.The customer stated he has not recovered from the symptoms and submitted a photo of the injuries.This was assessed as a serious injury.The user manual states, ¿the headgear should fit comfortably, and the mask should not dig into your skin.If your skin bulges around the mask or if you see red marks on your face due to tightness, loosen the headgear.¿ additional information was received on 04-aug-2025 which stated, ¿the patient visited the dermatology department attached to the clinic and was diagnosed with a medical-related pressure ulcer (mdrpu).It was suggested that the wound is likely caused not by pressure but by the use of the new mask.Additionally, it is estimated that it will take about a year for the scar to disappear.It seems that an ointment was prescribed, and there is a possibility that the patient will continue to visit the clinic regularly.¿ the device was returned to a philips service center for evaluation.The evaluation found that, ¿the mask was visually checked, and it was confirmed that there are no scratches or damages that would affect its use.When compared to a sample of the same type of mask, no abnormalities were found in the firmness or shape of the mask cushion gel, and it was confirmed to be equivalent.A review of the complaint history over the past three years revealed no previous reports of similar occurrences with the same mask, confirming this is the first report.Based on the above investigation results, it is determined that there are no abnormalities in the mask itself, and the mask is in normal condition.While a possible cause might be factors related to the patient's constitution or the handling, such as over-tightening of the headgear, the specific cause was not identified.¿ based upon the information provided and currently available remains to be contribution of the device to the patient outcome was confirmed by foreseeable use error- failure to wear the device as per the user manual.If additional information is obtained about this event, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to include the manufacturer's evaluation and additional information provided by the customer.The manufacturer received information that the comfort gel blue s mask left scratches on the ala of his nose when he started to use a new mask in june.The patient saw a dermatologist, and the doctor diagnosed the scratches as pressure wounds.The customer stated he has not recovered from the symptoms and submitted a photo of the injuries.This was assessed as a serious injury.The user manual states, ¿the headgear should fit comfortably, and the mask should not dig into your skin.If your skin bulges around the mask or if you see red marks on your face due to tightness, loosen the headgear.¿ additional information was received on 04-aug-2025 which stated, ¿the patient visited the dermatology department attached to the clinic and was diagnosed with a medical-related pressure ulcer (mdrpu).It was suggested that the wound is likely caused not by pressure but by the use of the new mask.Additionally, it is estimated that it will take about a year for the scar to disappear.It seems that an ointment was prescribed, and there is a possibility that the patient will continue to visit the clinic regularly.¿ the device was returned to a philips service center for evaluation.The evaluation found that, ¿the mask was visually checked, and it was confirmed that there are no scratches or damages that would affect its use.When compared to a sample of the same type of mask, no abnormalities were found in the firmness or shape of the mask cushion gel, and it was confirmed to be equivalent.A review of the complaint history over the past three years revealed no previous reports of similar occurrences with the same mask, confirming this is the first report.Based on the above investigation results, it is determined that there are no abnormalities in the mask itself, and the mask is in normal condition.While a possible cause might be factors related to the patient's constitution or the handling, such as over-tightening of the headgear, the specific cause was not identified.¿ based upon the information provided and currently available remains to be contribution of the device to the patient outcome was confirmed by foreseeable use error- failure to wear the device as per the user manual.If additional information is obtained about this event, a supplemental report will be submitted.

• Brand Name: S CMFRTGEL BLUE NSL MSK W/HGR JPN
• Common Device Name: CPAP/BIPAP NASAL MASK
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22585957
• Report Number: 2518422-2025-108170
• Device Sequence Number: 11897176
• Product Code: BZD
• UDI-Device Identifier: 00606959043756
• UDI-Public: (01)00606959043756(10)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: Other
• Device Model Number: 1079091
• Device Catalogue Number: 1079091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male