MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP S/T C-SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1061401
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
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 patient alleges headache, dizziness, respiratory irritation, and asthma.There is no allegation of serious or permanent harm or injury.No medical intervention was reported by the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
The manufacturer was previously 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 patient alleges headache, dizziness, respiratory irritation, and asthma.There is no allegation of serious or permanent harm or injury.No medical intervention was reported by the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a supplemental report will be filed.A pms clinical expert review determined that a serious injury was reported.Corrections were made in this report for sections b: adverse event/product problem and in section h: health impact.A final report is being filed at this time.If any additional information is received, a supplemental report will be filed.

• Brand Name: BIPAP S/T C-SERIES
• 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: 17927169
• Report Number: 2518422-2023-26470
• Device Sequence Number: 2810900
• Product Code: MNS
• UDI-Device Identifier: 00606959043961
• UDI-Public: 00606959043961
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1061401
• Device Catalogue Number: 1061401
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2012
• 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: Z-1973-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown