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Adverse Event Report

ALLIED HEALTHCARE PRODUCTS, INC. LSP OXYGEN REGULATOR   back to search results
Model Number L270-020
Event Date 08/20/1999
Event Type  Injury  
Event Description

Allied healthcare products, inc. Rec'd via phone call from distributor that a firefighter had rec'd 2nd degree burns on face and hands when he attempted to turn an oxygen regulator on that was attached to a "d" size cylinder.

 
Manufacturer Narrative

A captain stated that an lsp brand oxygen regulator model number l270-020 was indeed involved in a fire incident that occurred on friday august 20, 1999 at the facility. He stated that a firefighter had used the regulator on a d size cylinder the previous day, but, removed the regulator from the cylinder and had the cylinder refilled at another location. He then put the regulator back on and turned on the regulator to verify everything was functional when there was a flash fire. The firefighter sustained 2nd degree burns on hands and face and although these were serious burns he appeared to be holding up emotionally. Co then asked if the captain had the lot number of the regulator, but, the captain stated he did not. Co then asked, if the regulator had been retrofitted per the 1997 and 1999 recall. The captain stated that it had been retrofitted per the 1997 recall by changing the stainless steel filter to the sintered bronze filter, the captain stated that they were in the process of retrofitting the regulator per the 1999 recall; however, he did not believe this particular regulator had been retrofitted. Co went to ask about getting a copy of the incident report, the captain stated that they refer to this as a fire report and co would need to request a copy in writing to the director of finance and there would be a charge of $8. 00. The incident report number is 99-14754. Co also stated that if at all possible co would like to fly out and take pictures of the regulator and any and all equipment that was involved in the incident. The captain indicated that he would do so.

 
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Brand NameLSP OXYGEN REGULATOR
Type of DeviceOXYGEN REGULATOR
Baseline Brand NameLIFE SUPPORT PRODUCTS
Baseline Generic NameOXYGEN REGULATOR
Baseline Catalogue NumberL270-020
Baseline Model NumberL270-020
Baseline Device FamilyOXYGEN REGULATOR
Baseline Device 510(K) NumberK936187
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/01/1989
Date Ceased Marketing05/01/1999
Manufacturer (Section F)
ALLIED HEALTHCARE PRODUCTS, INC.
1720 sublette ave.
st. louis MO 63110
Manufacturer (Section D)
ALLIED HEALTHCARE PRODUCTS, INC.
1720 sublette ave.
st. louis MO 63110
Manufacturer (Section G)
ALLIED HEALTHCARE PRODUCTS, INC.
1720 sublette ave.
st. louis MO 63110
Manufacturer Contact
wayne karcher
1720 sublette ave
st. louis , MO 63110
(314) 771 -2400
Device Event Key230704
MDR Report Key238068
Event Key223376
Report Number1924066-1999-00017
Device Sequence Number1
Product CodeCAN
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Remedial Action Recall,Other
Type of Report Initial
Report Date 08/27/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/1999
Is This An Adverse Event Report? No
Device Operator Health Professional
Device MODEL NumberL270-020
Device Catalogue NumberL270-020
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/20/1999
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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