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

Model Number AUTO REMSTAR

Device Problems Leak/Splash (1354); Patient-Device Incompatibility (2682); Chemical Problem (2893)

Patient Problems Headache (1880); Dizziness (2194); Chemical Exposure (2570)

Event Date 06/10/2020

Event Type  Injury  

Event Description

Woke up with headache and dizziness from the chemical exposure due to off-gassing.Could distinctly smell the chemicals.Fda safety report id# (b)(4).

• Brand Name: REMSTAR AUTO A-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13002281
• MDR Text Key: 282297115
• Report Number: MW5106024
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030497
• UDI-Public: (01)00606959030497
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AUTO REMSTAR
• Device Catalogue Number: 560P
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: FLOWMAX; GLAUCOMA EYE DROPS; LIPITOR; LOW-DOSE ASPIRIN; METFORMIN
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic
• Patient Race: White