SURGEX POST VALVE 31-11-5000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-23 for SURGEX POST VALVE 31-11-5000 manufactured by Allied Healthcare Products, Inc..

Event Text Entries

[14873354] Fire department had a fire on one of their ambulances. The fire was between the puritan bennett oxygen regulator and the surgex post valve on the oxygen cylinder. The post valve had been turned on and they were adjusting the lpm setting when the fire started. No one was burnt.
Patient Sequence No: 1, Text Type: D, B5


[15452674] The investigation into the fire indicates the fire started after the cylinder post valve was turned on and the regulator was being adjusted between the two pieces at the plastic washer. Fda sent out a notification: oxygen regulator fires resulting from incorrect use of cga 870 seal on 6-19-2006.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1924066-2007-00004
MDR Report Key855302
Report Source05
Date Received2007-05-23
Date of Report2007-05-22
Date of Event2007-04-22
Date Mfgr Received2007-04-24
Date Added to Maude2007-06-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street1720 SUBLETTE AVE.
Manufacturer CityST. LOUIS MO 63110
Manufacturer CountryUS
Manufacturer Postal63110
Manufacturer Phone3147712400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGEX POST VALVE
Generic NamePOST VALVE
Product CodeECX
Date Received2007-05-23
Model Number31-11-5000
Catalog Number31-11-5000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key842778
ManufacturerALLIED HEALTHCARE PRODUCTS, INC.
Manufacturer AddressST. LOUIS MO 63110 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-05-23

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