MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1111178

Device Problem Unexpected Shutdown (4019)

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

Event Date 06/15/2020

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator unexpectedly shutdown and randomly would power on by itself.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was not confirmed.However, the device failed during run in.The devices board needs replaced to address the issue.Additionally, the right side panel, blower, box mount, flow tube, pressure tube and manifold were replaced for contamination which was not related to the malfunction/issue.The board was unable to be replaced due to a software issue.The device was scrapped.

• Brand Name: BIPAP A30
• 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: 18288792
• MDR Text Key: 330012774
• Report Number: 2518422-2023-34244
• Device Sequence Number: 1
• Product Code: MNS
• 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: Health Professional
• 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: Health Professional
• Device Model Number: 1111178
• Device Catalogue Number: 1111178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1