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

Model Number	1067P
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Dizziness (2194)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the patient could not tolerate the ventilator and stopped it.The patient alleges difficulty breathing and dizziness.Medical intervention was not specified.There is no allegation of serious or permanent harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
The manufacturer previously received information alleging the patient could not tolerate the ventilator and stopped it.The patient alleges difficulty breathing and dizziness.Medical intervention was not specified.Per the clinical review by the philips clinical expert it has been determined an adverse event occurred.Therefore, box b, adverse event/product problem, has been corrected to adverse event.The b5 statement has also had, "there is no allegation of serious or permanent harm or injury." removed.The initial reporter incorrectly reported the issue as a product problem.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
The manufacturer received information alleging the patient could not tolerate the ventilator and stopped it.The patient alleges difficulty breathing and dizziness.Medical intervention was not specified.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
• Common Device Name: 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: 18025062
• Report Number: 2518422-2023-27984
• Device Sequence Number: 7572975
• Product Code: MNS
• UDI-Device Identifier: 00606959039209
• UDI-Public: 00606959039209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1067P
• Device Catalogue Number: 1067P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/21/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown