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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Blister (4537); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2021

Event Type  Injury  

Event Description

Date is an estimate.Began what was thought to be hand, foot, and mouth (blisters on my tonsils and tongue).I waited 2 1/2 weeks to see a doctor following the initial symptoms.Pa stated it was not hand, foot, and mouth.Performed strep test.Negative.The pa could not determine diagnosis.The pa stated it was "some type of bacteria" and prescribed a z-pack.The first week in (b)(6) 2021, i came down with symptoms of a cold that lasted nearly a week then went into losing my voice.I went to a pa who prescribed an antibiotic.My voice slowly recovered between (b)(6).I saw an ent multiple times with no diagnosis.Was referred to the (b)(6) but i did not go in (b)(6) because symptoms somewhat subsided.I continue to have times where i my voice is impacted.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13061467
• MDR Text Key: 282726327
• Report Number: MW5106221
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic