MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. LIFE SUPPORT PRODUCTSOXYGEN REGULATOR; OXYGEN PRESSURE REGULATOR

Model Number L270-050

Device Problems Fire (1245); Flare or Flash (2942)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that a fire originated from an oxygen regulator when the oxygen cylinder was turned on.The reported event occured inside the (b)(6) while emts were transporting a patient.The company's l270-050 model regulators have not been manufactured since 1999.The labeling of the l270-050 regulator that was involved in the event shows that it was an aluminum regulator that had been retrofitted with brass internal components (specifically, a brass inlet fitting, a sintered bronze inlet filter, brass baffle, and a brass piston) as part of a recall action that was closed by the company and fda in 2000.The company was available to visually inspect the regulator.However, the regulator was not released to the company to conduct it's own testing.It was reported to the company that one emt received 2nd degree burns to his hand and was treated and released.The patient who was being transported had singed hair and was examined and released.The ongoing investigation into the event suggests that the regulator had a burn pattern indicating that the fire started on the inlet filter.High pressure oxygen forces fire to propagating the direction of flow.The bottom of the inlet stem which holds the filter was burned and all items downstream from this point were also burned.Upstream elements of the system did not exhibit thermal damage.Because the sintered bronze that lines the gas pathway does not burn on it's own, it is highly likely that contaminants were present on the filter and were the source of the ignition.Labeling on the product states that the introduction of contaminants may cause combustion and instructs the user to open the post valve slowly as this may lead to combustion if contaminants are present.The ifu for the product states to inspect the unit every two months and have the unit serviced every two years.The inspection, service, and maintenance history for this regulator over the last 20 years is presently unknown to the company.The company is unaware of any other reports of fires with it's retrofitted aluminum regulators or it's brass regulators in the last 20 years.The company is continuing it's investigation.

Event Description

A fire occured in an oxygen regulator.

• Brand Name: LIFE SUPPORT PRODUCTSOXYGEN REGULATOR
• Type of Device: OXYGEN PRESSURE REGULATOR
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: jon stillman ; 1720 sublette ave.; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 8927563
• MDR Text Key: 155415719
• Report Number: 1924066-2019-00001
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: L270-050
• Device Catalogue Number: L270-050
• Device Lot Number: 28167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization