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

Model Number 460P

Device Problem Nonstandard Device (1420)

Patient Problem Cancer (3262)

Event Date 12/19/2019

Event Type  Death  

Event Description

Began using a philips cpap machine in 2013.Diagnosed stage iv neuroendocrine carcinoma of the lung on (b)(6) 2019.Cancer metastasized to liver and bone.

• Brand Name: REMSTAR PRO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17172637
• MDR Text Key: 317638163
• Report Number: MW5118485
• 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: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 460P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2023
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM; CALCITRIOL ; CALCIUM; GABAPENTIN ; HYDROMORPHONE; IRBESARTAN; LORAZEPAM ; METHADONE ; METHYLPHENIDATE; MUPIROCIN ; OLANZAPINE; ONDANSETRON ; PEGILGRASTIM; SENNA-DOCUSATE
• Patient Outcome(s): Other; Life Threatening; Disability; Death
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White