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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-23 for * manufactured by *.

Event Text Entries

[227555] A 30psi regulator was put on to an (h cylinder) o2 cylinder set at 5psi by an engineering staff member. This caused a ventilator to fail during a procedure. The pt was bagged, no adverse outcome. The engineer did not know that o2 gas pressure needed to be set at 50psi and be tested for flow to run the ventilator. Biomed is taking steps to set up policies and train staff at facility. Rptr would like fda to expand advisory to all vessels. It is a recommendation by this biomed that the fda advisory on medical gas mix-ups be expanded to all vessels. All nfpa guidelines need to be followed at every facility, to include not only cryogenic vessels, but also all medical gas and industrial grade cylinders stored and used at medical facilities.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1022730
• MDR Report Key: 349501
• Date Received: 2001-08-23
• Date of Report: 2001-08-23
• Date of Event: 2001-08-02
• Date Added to Maude: 2001-09-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NA
• Generic Name: NA
• Product Code: CCN
• Date Received: 2001-08-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 338801
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-08-23