MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. 5 LT CONCENTRATOR - 220V 9153633992; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5LX

Device Problems Smoking (1585); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

Facility reported that a patient using an (b)(4) concentrator burned his upper lip and mustache while smoking with the oxygen on.The patient was educated about the risk of smoking while on oxygen.A no smoking sign was visible in the home.No malfunction of the product, mdr being filed based on the alleged injury.No alleged medical attention.

• Brand Name: 5 LT CONCENTRATOR - 220V 9153633992
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 2151 21; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 2151 21; CH 215121
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4712026
• MDR Text Key: 15233869
• Report Number: 3008262382-2015-01155
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 04/04/2015

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: IRC5LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2015
• Initial Date FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other