MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. 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 Partial thickness (Second Degree) Burn (2694)

Event Date 05/01/2015

Event Type  Injury  

Event Description

Patient reports she had been sleeping and upon waking she attempted to light a cigarette with her oxygen on via nasal canula, causing a flash burn to her face.Deep tissue burn noted to her left buccal area, periobital edema to both eyes noted.Patient refused treatment at the time of event.Patient went to (b)(6) 2015 for wound care and antibiotic treatment.Patient was transferred to (b)(4) for care per patient request (b)(6)2015.Injuries noted upon admission to vitas inpatient unit: right periorbital blister/second degree burn 3cmx7cm bilateral nares: wounds crusted over nose swollen to bottom lip.Left cheek: 11cmx7blister/second degree burn has broken and skin is pink.Mouth: 9cmx5cm blister/second degree burn.Chin is swollen and a large blister/second degree burn from ear to ear.Antibiotics ordered along with silvadene cream.

Manufacturer Narrative

(b)(4) - should additional information become available, a supplemental record will be filed.

• Brand Name: 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597
• 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: 4817406
• MDR Text Key: 5895787
• Report Number: 3008262382-2015-01253
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/11/2015

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?: Yes
• 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: 05/11/2015
• Initial Date FDA Received: 06/04/2015
• 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): Hospitalization
• Patient Age: 71