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

Model Number 1061401

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)

Event Date 08/21/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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
• 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: 17927169
• MDR Text Key: 325581273
• Report Number: 2518422-2023-26470
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959043961
• UDI-Public: 00606959043961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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
• Device Operator: Lay User/Patient
• Device Model Number: 1061401
• Device Catalogue Number: 1061401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other