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

Model Number	1109594
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer reassessed upon retrospective remediation review that this complaint is reportable in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging the blower and bottom enclosure are defective and errors related to the circuit board.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.On jun-03-2016, a device was returned to the manufacturer for investigation.During the evaluation of the device, the manufacturer visually inspected the device and found evidence of foam damage.In addition, there was an error with the system circuit board, the blower due to noise, and the bottom enclosure was broken.These parts were replaced to address the issue.The customer's complaint was confirmed.

• Brand Name: BIPAP A30 VENTILATOR
• Common Device Name: 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: 17439849
• Report Number: 2518422-2023-17778
• Device Sequence Number: 2494279
• Product Code: MNS
• UDI-Device Identifier: 00606959042728
• UDI-Public: 00606959042728
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• 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
• Operator of Device: Lay User/Patient
• Device Model Number: 1109594
• Device Catalogue Number: 1109594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2016
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown