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

Model Number CN1167HS

Device Problem Failure to Power Up (1476)

Patient Problems Cyanosis (1798); Dyspnea (1816); Pallor (2468); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : not returned to manufacturer.

Event Description

The manufacturer received information alleging a bipap avaps c-series device was not operating properly and the host does not run when the non-invasive ventilator is turned on.The patient symptoms include, "clear, mentally poor, shortness of breath, and cyanosis of the lips, breathing 26/min, spo2 88%,." the manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP AVAPS 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: 17241871
• MDR Text Key: 318264909
• Report Number: 2518422-2023-14634
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959015777
• UDI-Public: 00606959015777
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: CN1167HS
• Device Catalogue Number: CN1167HS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other