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

Model Number 1067P

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Dizziness (2194)

Event Date 09/06/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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 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
• 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: 18025062
• MDR Text Key: 327625125
• Report Number: 2518422-2023-27984
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959039209
• UDI-Public: 00606959039209
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1067P
• Device Catalogue Number: 1067P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other