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

Model Number DSX700S11F

Device Problem Material Fragmentation (1261)

Patient Problem Cancer (3262)

Event Date 10/23/2020

Event Type  Injury  

Event Description

Diagnosed with bladder cancer per urine test.Have had surgeries and treatments.Also i received a replacement dreamstation and foam appears to be breaking down within 6 weeks - it is the same as the recalled one.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: 13061785
• MDR Text Key: 282726436
• Report Number: MW5106228
• Device Sequence Number: 3
• Product Code: MNS
• 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: 12/19/2021
• 3 Devices were Involved in the Event: 1 2 3

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
• Device Model Number: DSX700S11F
• Patient Sequence Number: 1
• Treatment: CETIRIZINE; DOXAZOSIN; DOXYCYCLINE; DREAMSTATION BI-PAP; FLOMAX; HUMALOG INSULIN; LANTUS ; LEVOTHYROXINE; LISINOPRIL; MULTI VITAMIN ; PHENYTOIN SODIUM; ROPINIROLE; SERTRALINE; SIMVASTATIN; TYLENOL
• Patient Outcome(s): Other; Life Threatening; Disability; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White