MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY ROSCOE; REGULATOR

Model Number RMI-08MINI

Device Problem Explosion (4006)

Patient Problems Burn(s) (1757); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

This hospital had a roscoe regulator explode and cause a small fire.The hospital risk management notified compass' customer yesterday ((b)(6) 2018).He said the incident occurred 2-3 weeks ago.The patient using the regulator was not injured, however, a nurse was injured.The nurse suffered a broken foot & burns on her arm.When the explosion occurred, it blew the nurse back 3 feet into a wall, and her foot became entangled in the (patient's) wheelchair.

• Brand Name: ROSCOE
• Type of Device: REGULATOR
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY; yunyang industrial park; danyang city, jiangsu jiangsu 21230 0; CH 212300
• MDR Report Key: 8176633
• MDR Text Key: 130763089
• Report Number: 3012316249-2018-00062
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RMI-08MINI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Distributor Facility Aware Date: 11/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other