MAUDE Adverse Event Report: RESPIRONICS, INC. GARBIN VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1058180
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Cough (4457); Unspecified Respiratory Problem (4464)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging that a patient experienced vertigo, lightheadedness, headache, cough, and chest pressure, irritation and dryness of the respiratory tract, nose and eyes when using a ventilator.In addition, the patient alleged experiencing an "acid" smell.No medical intervention was reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The initial report sent on july 24.2023 was missing the following verbiage in the b5 section: "the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices." in addition, the recall number listed in section h as "res 88058" was incorrect and the correct recall reference number is "res 88071".
Event or Problem Description
The manufacturer was contacted 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 that a patient experienced vertigo, lightheadedness, headache, cough, and chest pressure, irritation and dryness of the respiratory tract, nose and eyes when using a ventilator.In addition, the patient alleged experiencing an ""acid"" smell.No medical intervention was reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer was contacted 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 that a patient experienced vertigo, lightheadedness, headache, cough, and chest pressure, irritation and dryness of the respiratory tract, nose and eyes when using a ventilator.In addition, the patient alleged experiencing an "acid" smell.No medical intervention was reported.The medical device associated with this complaint is currently under legal hold.As a result, philips is unable to proceed with device evaluation activities.This restriction prevents access to the device for inspection, testing, or analysis.If additional information becomes available, philips will assess the according to regulatory obligations and perform any necessary reporting activities to the appropriate competent authorities.

• Brand Name: GARBIN VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17379099
• Report Number: 2518422-2023-16482
• Device Sequence Number: 6118356
• Product Code: CBK
• UDI-Device Identifier: 00606959022768
• UDI-Public: 00606959022768
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2025

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: Other
• Device Model Number: 1058180
• Device Catalogue Number: 1058180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 07/11/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 07/27/2023; 11/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2012
• 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 88071
• Patient Sequence Number: 1
• Patient Sex: Unknown