MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PERFECTO2 V WITH SENSOR 9153650799; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5PO2V

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017); Noise, Audible (3273)

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

Event Date 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

There was no malfunction of the device that caused/contributed to the alleged injury.The patient was smoking while using the device.At this time, no confirmation that the death was related to the incident.No return is expected at this time.Per user manual 1193323-a, page 9 danger risk of death, injury, or damage from fire.To avoid fire, death, injury or damage: do not smoke while using this device.Do not use near open flame or ignition sources.Do not use any lubricants on concentrator unless recommended by invacare.No smoking signs should be prominently displayed.Avoid creation of any spark near oxygen equipment.This includes sparks from static electricity created by any type of friction.Keep all matches, lighted cigarettes, electronic cigarettes or other sources of ignition out of the room in which this concentrator is located and away from where oxygen is being delivered.Keep the oxygen tubing, cord, and concentrator out from under such items as blankets, bed coverings, chair cushions, clothing, and away from heated or hot surfaces including space heaters, stoves, and similar electrical appliances.Should additional information become available a supplemental record will be filed.

Event Description

The patient was wearing oxygen 4 lpm via nc and 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 startled the patient's dog (a pit bull mix) 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 she was able to heal them herself with antibiotic ointment and bag balm.On friday the physician made a visit and ordered a 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 WITH SENSOR 9153650799
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6181027
• MDR Text Key: 62826330
• Report Number: 1031452-2016-03653
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/07/2016

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: IRC5PO2V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/16/2016
• 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): Death
• Patient Age: 65
• Patient Weight: 77