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

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging the device did not work and was replaced with another ventilator.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP AVAPS
• 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: 18007021
• MDR Text Key: 326532896
• Report Number: 2518422-2023-27792
• 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: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/24/2023

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 Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/25/2023
• 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