MAUDE Adverse Event Report: RESMED PTY LTD STELLAR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number	150
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Bipap (resmed stellar) stopped functioning with no appreciable pressure being delivered - screen also noted to be blank.Rn attempted to turn device back on, however, reported to keep turning off.Patient with desaturation to spo2 60's and placed back on nasal oxygen without further incident and improvement in saturation.Bipap machine pulled from service and replaced with substitute machine.Pulled machine noted to be markedly warm to touch.

• Brand Name: STELLAR
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESMED PTY LTD; 9001 spectrum center blvd; san diego CA 92123
• MDR Report Key: 13782166
• Report Number: 13782166
• Device Sequence Number: 13881772
• Product Code: MNT
• UDI-Device Identifier: 00619498241613
• UDI-Public: (01)00619498241613
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/28/2022
• Report Date (Section F): 02/28/2022

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: 150
• Device Catalogue Number: 24161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 02/28/2022