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

Model Number 460P

Device Problem Use of Device Problem (1670)

Patient Problem Cancer (3262)

Event Date 04/05/2022

Event Type  Injury  

Event Description

Began using philips brand cpap in 2014.Diagnosed with stage 4 metastatic colon cancer on (b)(6) 2022.Cancer has spread to liver, lungs and spine.Reference report: mw5118398.

• Brand Name: REM STAR PRO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17135521
• MDR Text Key: 317335166
• Report Number: MW5118397
• 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: 06/12/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2023
• Patient Sequence Number: 1
• Treatment: GABAPENTIN, ATROPINE, DECADRON, ADRUCIL, ESOMEPRAZOLE MAGNESIUM, ONDANSETRON, AMOXICILLIN, OMEPRAZOLE, TROSPIUM CHLORIDE, LASIX, POTASSIUM CHLORIDE, TIZANIDINE, TRAMADOL, PEGRILGRASUM, FAMOTIDINE, CICLOPIROX OLAMINE, FLUOCINONIDE. ; ROBITUSSIN, ALEVE, CLARITIN, TYLENOL.
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White