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I am trying to forward a time sensitive issue with regards to my mom's oxygen concentrator and vinyl supply hose, which has a very dangerous and potential life threatening design flaw as well as the supply hose used with oxygen machines.My mom has encountered catastrophic failure of the supply hose (severe crimping) which has restricted her oxygen flow.The brass supply connection nipple on the machine points nearly straight up, which is a terrible design flaw as the hose collapses on itself (crimps) frequently under its own weight.The nipple should point vertically down to eliminate potential hose crimp as depicted in the photos.The machine itself is very reliable for pumping overall oxygen supply.The supply is only as good as the final delivery though.A much more stable supply hose is desperately needed for those pts who are somewhat mobile around their home.Or, a more stable "leader hose" should be provided to connect at the machine to run to the floor level, with less vulnerability for crimping and restricted airflow.I have found my mom twice now with crimped hoses and associated sickness from the restricted oxygen flow.It is hard to believe this issue has not been brought to the attention of the fda, considering the nationwide use of oxygen concentrators similar to my mom's.The device is supplied by (b)(6), and i'm not aware of the exact model other than what is in the picture.It is my understanding the green vinyl supply hose is industry standard.Unfortunately, change only seems to happen concurrent with legal action and financial penalties.My intent is to file the form on the fda website, but was not sure of the ability to attach photo evidence, which is worth a thousand words or description.It really isn't complicated, but is very serious.I'm left wondering how many people may have died prematurely with a copd condition which may have been contributed to these avoidable design flaws described above.The restrictive oxygen flow would/could easily have been masked as the cause as copd pts typically fail from respiratory issues from the internal perspective.Due to the inherent time sensitivity, i truly would prefer to talk to a person directly who may be able to expedite my concern.As it is now, i don't sleep well at night wondering if the hose is crimping and restricting my mom's vital oxygen supply.
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Additional info received from the reporter on 01/29/2015: i am writing in response to the fda's "boiler plate" response to my original safety complaint/report (assigned access# mw5039882.Unfortunately, the response specifies that my "life threating complaint/concern" is to be entered into the maude database and "monitored" to determine "trends".By the time a trend is established, there are sure to be deaths, which could have been prevented with fda intervention or more urgent investigation into the safety concern presented.Truly, this is unacceptable for a potential life threatening medical equipment safety concern.It's hard to believe an agency with the responsibility and authority to effect policy and prevent unnecessary deaths by enforcing recalls and or public warning does not have a priority pipeline for those safety reports which have immediate urgency for life or death implications.Essentially, your response tells me the fda will "monitor" similar reports as mine for trends.I am notifying you that my concern of urgency can/will prevent potential deaths related to the oxygen concentrator identified above.As i reported, on 2 occasions, i have found my (b)(6) mom's oxygen concentrator hose kinked and restricting oxygen flow at the point of connection on the device.She complained of feeling "sick" which is a symptom of lack of oxygen for pts with copd conditions.Essentially, i do not sleep well at night in fear of this medical device's potential failure and restricted oxygen flow to my mom.And her loss of life.I am left wondering if i were writing this letter to inform you of her death as a contributory or direct result of the oxygen concentrator's design safety flaw, would the existing report in the fda's maude come out of "monitor trend status" and changed to a more actionable response, after the fact? (b)(6) is the supplier, not the mfr.I did contact them, however, it was my understanding there was nothing they could/would do, similar to the fda's "monitor trends" status.We all know companies are only moved to action by law.Or financial loss risks (lawsuit).I am going to express my concern on this issue with my local congressman, as i trust his/her voice will be louder than mine.There are far too many waves in this ocean for me to navigate alone.I am only continuing to engage this issue because i truly feel there are lives at risk, to include my mom, any my voice can/will prevent unnecessary deaths.My report specifically describes a combined design flaw of the oxygen concentrator having its connection point in a vertical position which lends to hose collapse at that point.The connection needs to be designed to connect from the bottom, thus relieving stress on the supply hose.Or, a mandatory "rigid" leader supply hose required with this device to connect at the device and at the floor level for the regular supply hose connection.No rocket science on this.Please find enclosed a picture of my specific complaint of the oxygen concentrator and supply hose connection kink which restricted my mom's oxygen flow.A picture is worth a thousand words.And may be support saving a life.
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