FDA Adverse Event Injury Summary report: N

ROSCOE

MDR report key: 13366109 · Received January 27, 2022

Report

Report Number: 3012316249-2022-00001
Event Type: Injury
Date Received: January 27, 2022
Date of Event: September 20, 2021
Report Date: February 4, 2022
Manufacturer: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY
Product Code: CAN
Adverse Event: Yes
Product Problem: Yes
Report Source: Distributor report
Reporter Location: TX, US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Description of Event or Problem · 0

WE REPRESENT AND WRITE ON BEHALF OF (B)(6) RELATED TO AN INCIDENT THAT OCCURRED ON (B)(6) 2021, WHEN AN OXYGEN CYLINDER ALLEGEDLY EXPLODED AND CAUGHT FIRE, AND IN WHICH TWO PERSONS, THE PATIENT'S DAUGHTER AND A HOSPICE NURSE, SUFFERED BURNS THAT REQUIRED MEDICAL TREATMENT. THERE WAS ALSO SOME PROPERTY DAMAGE TO THE CARPETED FLOOR. TWO ROSCOE MEDICAL PRODUCTS WERE INVOLVED: ROSCOE M6 OXYGEN TANK SERIAL #:(B)(4), ROSCOE REGULATOR RMI-15ST, SERIAL #:(B)(4) LOT 1502803. THE OXYGEN TANK AND REGULATOR ARE SEQUESTERED AT (B)(6) FACILITY IN (B)(6). THE SERIAL NUMBER BEING REPORTED IS (B)(4). IF ACCURATE, THIS WOULD NOT BE A (B)(4) DEVICE AS THIS ITEM HAS NOT BEEN PURCHASED FROM THIS SUPPLIER SINCE 2017. ONCE FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE FILED. THE OXYGEN TANK IS A PRIVATE LABELED M6 OXYGEN TANK. IT WAS SOLD BY (B)(4) BUT IS A DISTRIBUTED ITEM. THE DISTRIBUTOR WILL BE NOTIFIED.

Description of Event or Problem · 0

PER SUPPLIER: WE CHECKED THIS PO AND FOUND IT WAS PRODUCED IN YEAR OF 2016. AND THE SHELF LIFE OF THE OXYGEN REGULATOR IS ONE YEAR AND THE PARTS NEEDS ALSO TO BE REPLACED REGULARLY. PER SUPPLIER: ITEM WAS SHIPPED TO COMPASS HEALTH BRANDS ON PO (B)(4), SHIP DATE (B)(6), 2016.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
112573	ROSCOE	STANDARD REGULATOR, 0-15 LPM	CAN	JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY	RMI-15ST

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Hospitalization