MEDICAL AIR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-05 for MEDICAL AIR * manufactured by *.

Event Text Entries

[206515] Nfpa 99 is being changed to allow a greater level of particulate in the gas piping and a larger size of particulate. Former nfpa 99 standard permitted 1 mg/cubic meter at 0. 45 micron. New proposed standard is 5 mg/cubic meter at 1 micron. This is being pushed through the nfpa 99 piping committee by members of the committee who are system verifiers - identified and not identified on the nfpa committee, possibly producing an unbalanced committee - system verifiers work for the installing medical gas system contractor and have a reason to lower the "standard" for medical air. Rptr thought that medical air was a drug and that contaminates were not allowed. Are there two levels of standards for the delivery of medical air to the pt? One for the medical gas provider to the hosp and the other lower standard for the hosp provided medical air. Since there are no biological studies conducted on medical air systems installed in healthcare facilities there is no means to determine that medical air -a drug- delivery system -piping- is contaminating the delivered drug to the pt. When will the fda start treating the medical gas piping systems at the healthcare facilities like the drug delivery system it is? Will this need to be tried in the legal system to get some sort of order to this process? Before responding look at the requirements of the system verifier in nfpa 99. The verifier does not have any responsibility to anyone, only to the installing contractor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1022359
• MDR Report Key: 341524
• Date Received: 2001-07-05
• Date of Report: 2001-07-05
• Date Added to Maude: 2001-07-13
• 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: OTHER HEALTH CARE PROFESSIONAL
• 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: MEDICAL AIR
• Generic Name: MEDICAL GAS PIPING SYSTEMS
• Product Code: FRF
• Date Received: 2001-07-05
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 330860
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-07-05