MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY ROSCOE; STANDARD REGULATOR, 0-15 LPM

Model Number RMI-15ST

Device Problem Explosion (4006)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 09/20/2021

Event Type  Injury  

Event Description

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.

Event Description

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.

• Brand Name: ROSCOE
• Type of Device: STANDARD REGULATOR, 0-15 LPM
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY; no.1 baisheng road development; danyang jiangsu, 21230 0; CH 212300
• MDR Report Key: 13366109
• MDR Text Key: 284535823
• Report Number: 3012316249-2022-00001
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: RMI-15ST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2022
• Distributor Facility Aware Date: 01/06/2022
• Device Age: 67 MO
• Date Report to Manufacturer: 02/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization