MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PRO C-FLEX AUTO IQ SYSTEM ONE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Dizziness (2194); Low Oxygen Saturation (2477); Convulsion/Seizure (4406); Unspecified Immune System Problem (4435); Eye Pain (4467)

Event Date 06/08/2012

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused an auto accident in 2012 from the use of the device, seizures, coagulopathy disorder, hyperoxia, dizziness, nose bleeds, eye pain, nasal polyps, chronic inflammation, asthma, recurring infection, allergies, drug sensitivity and immunes disorders.The patient did report to receive medical intervention and was hospitalized and placed on disability.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

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 previously received information alleging an issue related to a cpap device's sound abatement foam became degraded and and caused an auto accident in 2012 from the use of the device, siezures, coagulopathy disorder, hyperoxia, dizziness, nose bleeds, eye pain, nasal polyps, chronic inflammation, asthma, recurring infection, allrgies, drug sensitivity and immunes disoprders while using this device.The patient did not report to receive medical intervention.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.

• Brand Name: REMSTAR PRO C-FLEX AUTO IQ SYSTEM ONE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 15206 ; 2673970028
• MDR Report Key: 15086091
• MDR Text Key: 296407787
• Report Number: 2518422-2022-63241
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention; Disability