MAUDE Adverse Event Report: RESPIRONICS INC. DREAMSTATION AUTO BIPAP HUMCELL DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX700HIIC

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Pulmonary Emphysema (1832); Nasal Obstruction (2466)

Event Date 03/01/2021

Event Type  Injury  

Event Description

On "(b)(6) 2019 began dreamstationaut" the eyes started having no tears (b)(6) 2019.Double sets of eye plugs are put in every six month appointment.A bronchoscopy was performed for emphysema.A major operation (remove nose obstruction/spur and rebuild) was scheduled and done, (b)(6) 2021.And, now we are informed by pulmonary lungs specialist, the blood work and urine now shows lower kidneys and lower liver results.(b)(6).Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO BIPAP HUMCELL DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 12681987
• MDR Text Key: 278220798
• Report Number: MW5104868
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700HIIC
• Device Catalogue Number: MURRYSVILLE
• Device Lot Number: IP22
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 103