MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP V30 AUTO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1111178

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/01/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator had stopped during use.There was no harm or injury reported.No medical interventions were specified.During the evaluation of the device at the manufacturer's service center, the customer's allegation was confirmed.The service engineer determined the ui panel, right side panel, blower, pressure tube, flow tube, box mount, pc assembly and manifold all needed to be replaced.The device had a software issue and was ultimately scrapped.

• Brand Name: BIPAP V30 AUTO
• 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: 18446094
• MDR Text Key: 331934907
• Report Number: 2518422-2024-00596
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959049635
• UDI-Public: 00606959049635
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113053
• 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

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: Health Professional
• Device Model Number: 1111178
• Device Catalogue Number: 1111178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2019
• 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