MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP V30 AUTO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1111155
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the device was alarming, and when staff entered the patient's room, the device was off, and the screen was blank while in patient use.There was no patient harm or injury and will be reported as a product problem.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP V30 AUTO
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20260917
• Report Number: 2518422-2024-100771
• Device Sequence Number: 12836724
• Product Code: MNS
• UDI-Device Identifier: 00606959039377
• UDI-Public: (01)00606959039377
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• 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
• Device Model Number: 1111155
• Device Catalogue Number: 1111155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown