MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMWISP NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1137916
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation that an end user experiences a buzzing noise from a cochlear implant in left ear while wearing the dreamwisp nasal mask with magnetic clips.There was no report of patient harm or injury.There was no report of medical intervention.No product will be returned for investigation.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.
Additional Manufacturer Narrative
Not returned to manufacturer.

• Brand Name: DREAMWISP NASAL MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 15958951
• Report Number: 2518422-2022-101507
• Device Sequence Number: 12179549
• Product Code: BZD
• UDI-Device Identifier: 00606959050976
• UDI-Public: 00606959050976
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1137916
• Device Catalogue Number: 1137916
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES90705
• Patient Sequence Number: 1
• Patient Sex: Male