MAUDE Adverse Event Report: GRACE HEALTHCARE MEDICAL MEDICAL GRADE OXYGEN CYLINDERS; REGULATOR, PRESSURE, GAS CYLINDER

Device Problem Nonstandard Device (1420)

Patient Problem Convulsion/Seizure (4406)

Event Date 10/20/2020

Event Type  Death  

Event Description

Husband was on oxygen from grace healthcare medical since 2017 the morning of (b)(6) he started having convulsions while on the oxygen.Got a letter from them on 4/20/2021 stating a voluntary recall on medical grade oxygen.He passed away on (b)(6) 2020.I do not have the product anymore.When my husband passed away i called them to come pick up the tanks but he was on the oxygen 24/7.Fda safety report id#: (b)(4).

• Brand Name: MEDICAL GRADE OXYGEN CYLINDERS
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): GRACE HEALTHCARE MEDICAL; 114 main ave n; magee MS 39111
• MDR Report Key: 11723435
• MDR Text Key: 247480730
• Report Number: MW5100958
• Device Sequence Number: 1
• Product Code: CAN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 61 YR
• Patient Weight: 111