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

Model Number DSX700H11

Device Problems Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)

Patient Problems Sore Throat (2396); Cough (4457)

Event Date 02/03/2020

Event Type  Injury  

Event Description

Persistant irritated throat and cough believed caused by faulty product.About a 1 1/2 years i started developing a constant irritated throat and cough.I had an upper scope to stretch my throat, but it was not to check my irritation or cough.I have not had an evaluation on the cause, but i believe that bipap could have caused the condition.

• Brand Name: DREAMSTATION AUTO BIPAP HUM DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12657479
• MDR Text Key: 277397454
• Report Number: MW5104692
• 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: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 87 YR
• Patient Weight: 78