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

Model Number DSXHCP

Device Problem Insufficient Information (3190)

Patient Problems Asthma (1726); Dry Eye(s) (1814); Headache (1880); Itching Sensation (1943); Sleep Dysfunction (2517); Cough (4457)

Event Type  Injury  

Event Description

I noticed a change in my sleep quality several months ago.Then began to have headaches and coughing, and asthma is worsening.My eyes are also dry and itchy.Fda safety report id# (b)(4).

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS, INC.
• MDR Report Key: 12407325
• MDR Text Key: 269766992
• Report Number: MW5103655
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025639
• UDI-Public: (01)00606959025639
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSXHCP
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 111