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..
[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
Report Number | 1924066-2007-00004 |
MDR Report Key | 855302 |
Report Source | 05 |
Date Received | 2007-05-23 |
Date of Report | 2007-05-22 |
Date of Event | 2007-04-22 |
Date Mfgr Received | 2007-04-24 |
Date Added to Maude | 2007-06-05 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Street | 1720 SUBLETTE AVE. |
Manufacturer City | ST. LOUIS MO 63110 |
Manufacturer Country | US |
Manufacturer Postal | 63110 |
Manufacturer Phone | 3147712400 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SURGEX POST VALVE |
Generic Name | POST VALVE |
Product Code | ECX |
Date Received | 2007-05-23 |
Model Number | 31-11-5000 |
Catalog Number | 31-11-5000 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 842778 |
Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
Manufacturer Address | ST. LOUIS MO 63110 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2007-05-23 |