MAUDE Adverse Event Report: RESPIRONICS, INC. M, DREAMWISP NSL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1137934

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Gastrointestinal Problem (4491)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging that the patient's dentist detected perimplantitis and loss of gum support up to 70% in some areas.Patient didn't seek medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: M, DREAMWISP NSL
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18483428
• MDR Text Key: 332549904
• Report Number: 2518422-2024-01372
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959051072
• UDI-Public: 00606959051072
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K140980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1137934
• Device Catalogue Number: 1137934
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other