MAUDE Adverse Event Report: INVACARE PERFECTO2 V CONCENTRATOR; OXYGEN CONCENTRATOR

Model Number IRC5P02V

Device Problems Fire (1245); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 11/26/2016

Event Type  Death  

Event Description

Patient was wearing oxygen 4 lpm via nc, she lit a cigarette and there was a flash fire and large bang noise.The fire caused second degree burns to the patient's face and the noise started the patient's dog (a pit bull mix) and the dog bit the patient on the hand.The patient did not notify anyone of this until a routine scheduled visit was made by the rn case manager on (b)(6) 2016.The patient declined to seek treatment at the local hospital or clinic, she reported that she has sustained flash burns on her face twice in the past and was able to heal them herself with antibiotic ointment and bagbalm.On friday the physician made a visit and ordered tdap vaccine, and keflex.The physician reports that the patient has reported that she will not use the oxygen because she is afraid of what might happen.The rn case manager attempted to visit the patient on friday afternoon, but the patient would not put the dog up and declined to have the nurse in the home.On saturday ((b)(6) 2016), (b)(6) received a call from the (b)(6), stating that the patient was found dead by the grandson's girlfriend who also resided in the home.

• Brand Name: PERFECTO2 V CONCENTRATOR
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): INVACARE; 1 invacare way; elyria OH 44036
• MDR Report Key: 6178213
• MDR Text Key: 62540228
• Report Number: 6178213
• Device Sequence Number: 0
• Product Code: CAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: IRC5P02V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2016
• Distributor Facility Aware Date: 12/01/2016
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 12/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 18" WHEELCHAIR; COMMODE; E CYLINDER SYSTEM
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 77