MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP S/T C SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1067P

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 05/20/2023

Event Type  Death  

Manufacturer Narrative

The exact year of event/death was not available at the time of this report.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information stating a death occurred while a bipap s/t c series ventilator was in use by a patient.The family member reported that on (b)(6), there was no abnormal alarm while the device was in use.The power was cut off between 2:09am to 2:38am on (b)(6) and the system was shut down.The family member states after the power were restored, the patient was found dead at 5am due to the patient's inability to move to turn the treatment button back on.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported: the manufacturer received information stating a death occurred while a bipap s/t c series ventilator was in use by a patient.The family member reported that on may 19, there was no abnormal alarm while the device was in use.The power was cut off between 2:09am to 2:38am on may 20 and the system was shut down.The family member states after the power were restored, the patient was found dead at 5am due to the patient's inability to move to turn the treatment button back on.The exact year of event/death was not available at the time of this report.New information: additional information regarding the date of death and event date was added to section b.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP S/T C SERIES
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 18660277
• MDR Text Key: 334774596
• Report Number: 2518422-2024-06098
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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?: Yes
• Device Operator: Other
• Device Model Number: 1067P
• Device Catalogue Number: 1067P
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death