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

Model Number 1038917

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Sore Throat (2396); Neck Stiffness (2434); Cough (4457); Unspecified Respiratory Problem (4464); Insufficient Information (4580)

Event Date 03/29/2024

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch (mw5152599) 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 dyspnea, chest issues, fatigue, headache, hypersensitivity, pain, rash, urinary tract infections, back pain, neck stiffness, sore throat, cough and unspecified respiratory problems.There was also an allegation of foam degradation of the device.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

• Brand Name: BIPAP AUTO SV
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19152551
• MDR Text Key: 340709174
• Report Number: 2518422-2024-21253
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1038917
• Device Catalogue Number: 1038917
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other