MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIP 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5LX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 12/08/2014

Event Type  Injury  

Event Description

Hospice reported that a patient was smoking while using her irc5lx oxygen concentrator.User sustained burns to her face, lips and fingers.Patient was sent to hospital.No malfunction of the product.Injury resulted due to the use of the device in nonconforming terms.The hospice understands the injury was not due to equipment but patient's non compliance.Concentrator has been quarantined.

• Brand Name: 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE REHABILITATION EQUIP; no.435 xieyu street; suzhou industrial park; jiangsu, p.rc. 2150 26; CH 215026
• Manufacturer (Section G): INVACARE REHABILITATION EQUIP; no.435 xieyu street; suzhou industrial park; jiangsu, p.rc. 2150 26; CH 215026
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4383680
• MDR Text Key: 20773169
• Report Number: 3008262382-2015-00004
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/20/2014

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?: No
• Initial Date Manufacturer Received: 12/20/2014
• Initial Date FDA Received: 01/06/2015
• 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