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

Model Number IN551S

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Fluid Discharge (2686); Pancreatitis (4481); Skin Inflammation/ Irritation (4545)

Event Date 10/26/2019

Event Type  Injury  

Event Description

Acute pancreatitis (b)(6) 2019 no reason found that time but after i read today the toxic effects of this foam on liver and kidneys i decided to report the incident.Sinusitis attacks w/blood stained discharges, frequency increased to be monthly in last 2-3 years till i change the machine on (b)(6) 2021.Loss of smell for few months in early 2019.Headache (nearly every morning in last 2-3 years-totally resolved after i changed machine).Continues skin irritations of nostrils and eyelids (nearly every week in last 2-3 years-totally resolved after i changed machine) i had to buy lots of sleeping pillows to elevate upper body and head to sleep side and high; to avoid using the machine or not to be able to use the machine due to above problems.As being a physician i dealt myself or consulted with my friends for most minor problems above.But i admitted to er for the first one.I am ready to co-operate on all these issues.Thank you in advance for your evaluation.Dr.(b)(6) auditor - (b)(6) health systems.Fda safety report id# (b)(4).

• Brand Name: REMSTAR AUTO A-FLEX W/SD CARD INT (SYSTEM ONE CPAP)
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15418838
• MDR Text Key: 299964648
• Report Number: MW5112021
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: H906IN551S0O
• UDI-Public: +H906IN551S0O/$P0555760479E5
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: IN551S
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White