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

Model Number 560P

Device Problem Use of Device Problem (1670)

Patient Problem Cancer (3262)

Event Date 06/25/2021

Event Type  Injury  

Event Description

Started using philips cpap in 2011.Diagnosed with myeloproliferative neoplasms (b)(6) 2021.

• Brand Name: REMSTAR AUTO SYSTEM ONE CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17218565
• MDR Text Key: 318138188
• Report Number: MW5118882
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 560P
• Patient Sequence Number: 1
• Treatment: FOLIC ACID.; HYDROXYUREA.; LEVOTHYROXINE.; LOSARTAN.
• Patient Outcome(s): Life Threatening; Disability; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian