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

Model Number 1111178

Device Problems Electrical /Electronic Property Problem (1198); No Pressure (2994)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging the device had d/t alarm, no pressure was registering from the patient's mask also, the unit shut off multiple times and unit is alarming.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.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• 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: 18337492
• MDR Text Key: 330619509
• Report Number: 2518422-2023-35887
• 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: User Facility
• Reporter Occupation: Other
• 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: Other
• Device Model Number: 1111178
• Device Catalogue Number: 1111178
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1