MAUDE Adverse Event Report: RESPIRONICS, INC RESPIRONICS EVERGO PORTABLE OXYGEN CONCENTRATOR; OXYGEN PORTABLE

Device Problems Premature Discharge of Battery (1057); Failure to Charge (1085); Device Displays Incorrect Message (2591)

Patient Problems Anxiety (2328); No Code Available (3191)

Event Date 08/01/2014

Event Type  Injury  

Event Description

Re: "defected" portable oxygen concentrator.Dear (b)(6): this is a complaint about the horrible, life threatening incident i had with rental of respironics evergo portable oxygen concentrator (poc) from your location, which was to be my only source of oxygen for three (3) days.Chronology of events: (b)(6) 2014: i cleared through my physician to fly to (b)(6) with a portable oxygen concentrator.(b)(6) 2014: (b)(6) airlines consent form completed by my physician.(b)(6) 2014: went to (b)(6), left (b)(6) cash deposit for poc to pick up (b)(6) 2014.(b)(6) 2014: picked up poc and took it home to charge the batteries, would not charge.(b)(6) 2014: took poc back to (b)(6), given another battery, again took it home and tested poc for about 30 minutes, then the technical fault alarm and oxygen concentration alarm came on which states change to another source of oxygen and contact your equipment provider.(b)(6) 2014: took this malfunctioning poc back to (b)(6), showed mr.(b)(6) that it was not working according to the manual.He gave me another one, same model and i sat there for 45 minutes testing it.Took it home and charged up all 3 batteries.(b)(6) 2014: arrived 6:10am at (b)(6)airport, started using poc for 7:25am flight, arrived (b)(6) airport 9:15am.At 9:40am the alarms on poc went off.I panic because this was to be my only source of oxygen for the weekend.According to the manual 2 batteries = 4 hours plus the extra 1 = 2 hours for a total of 6 hours.Found a plug at the airport and plugged poc in the outlet, charged enough to get me to my nephew's home and plug it in again and the alarms continued to go off.At approx 1:50pm i called (b)(6) in (b)(6) to let them know that i had an emergency because this poc was not working and i needed oxygen.Talked to ms.(b)(6) and she asked where i was and she would locate an oxygen supplier in the area and get back to me.I, also in panic mode, called (b)(6) corporate office complaint dept.Ms.(b)(6) did call me back and informed me that there was nothing she could do about the poc, but i could get some portable oxygen tanks at (b)(6).I did go and get 8 "c" tanks since they had no replacement.(b)(6) 2014: used portable tanks all day.(b)(6) 2014: used portable tanks all day and took it to the airport and sat there until 9pm until i went through security for the 10:03 return flight, started poc (allegedly batteries fully charged).An hour and 10 minutes into the flight the alarms go off again, and i did panic.I just prayed like (profanity).I was out of oxygen for 40 minutes, this was a life threatening occurrence.I had already called my niece before boarding plane in (b)(6) to meet me at (b)(6) airport with oxygen.To resolve this complaint, i am requesting full refund of my (b)(6) deposit and the 8 tanks received and returned to the (b)(6) facility i will not be billed for nor my insurance carrier.This was medically necessary equipment and (b)(6)failed substantially and improvement is needed in the quality of poc rentals.Will await your reply.(b)(6).

• Brand Name: RESPIRONICS EVERGO PORTABLE OXYGEN CONCENTRATOR
• Type of Device: OXYGEN PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC
• MDR Report Key: 4034181
• MDR Text Key: 4727565
• Report Number: MW5037882
• Device Sequence Number: 1
• Product Code: CAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/06/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR