RESMED CPAP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for RESMED CPAP manufactured by Apria Healthcare.

Event Text Entries

[102334654] I have been trying since (b)(6) 2017 to obtain a cpap machine from apria healthcare. In (b)(6), they left a message stating that my machine was approved, and that they needed to "talk" to me before sending the machine. A woman left a number and a 5 digit phone extension. I called several times and left a message, and never heard back. It may or may not be, because after you left a message, instead of hanging up you need to press "#" and then a 3 before the message is sent (i discovered today). Her 3rd message stated that she would cancel my order if she didn't hear from me. The person stated that she only had certain business hours. We never connected. I received a bill in the mail for what i guess was the new machine, and i paid it (b)(6). I waited and waited, and nothing. So i called them and it seems that they have people outside the us with heavy accents reading from a script to respond. They stated that i needed to pay, i stated that i did, then they said that another authorization would need to be obtained. I told them it had been approved and shouldn't need another authorization. I also stated that my machine was/is dying and it needs to be replaced asap. They said my request would need to be sent to the "escalation department". There i was put on hold for 30 minutes the first time and about the same or more the second. (mind you i am at work) no one ever answered. I called again and said that i wasn't waiting and i want them to take care of the matter and have my equipment ready for pick up. Last thursday (b)(6), after many calls, the woman said that they would send the final paper work to my email address for me to fill out, scan and send back. (i should mention when amy left a message, she left an alternate phone number to call if she didn't answer. It was never picked up) today is (b)(6) and i have not received anything. I have left messages, and today noticed the 2 other steps in order to send your message... A process that i feel gets them out of receiving voice mails. There are other serious problems here: the length of time it has taken to get a machine. I stated that my current one is dying, it was confirmed i use it 8 hours/night, 7 days a week by my sd card. Secondly, their phone system sucks, and needs an upgrade. If you have a 5 digit extension, you need to speak slowly so that people can capture the number. They very quickly tell you their extension. So i had to listen several times to the message for the number. Also there should be normal working hours ((b)(6)). Third, whoever is answering calls are obviously in a different country. They are reading from a script, at one point, this woman talked over me, wouldn't let me talk and kept saying that it was resolved, but didn't have any other information. Fourth, i am not the only victim of this company, there are many more, and our healthcare providers and insurance companies are relying on this business to provide critical medical care devices. It seems like they are the only game in town, so they can act and react at their leisure. Lastly, i was informed that i would be charged a monthly fee for my machine. I had mine for 5 years, use it religiously, but now am told that i will need to prove i use it before they will stop the charges. Really. I use it, my doctor wouldn't have renewed my prescription for a new one if i didn't. On a side note, i happened to mention apria to a co-worker and they rolled their eyes and stated, that their toddler son had needed crutches. He was working through apria, and he never got a thing, it was finally approved or ready to be delivered when it was time for his son's cast to be removed. We are being held hostage by this company and their practices and it needs to stop. They need to be seriously warned and possibly sanctioned for their practices. It doesn't take much research to find seriously negative reviews about the,.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075784
MDR Report Key7330346
Date Received2018-03-09
Date of Report2018-03-08
Date of Event2017-12-15
Date Added to Maude2018-03-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRESMED CPAP
Generic NameCPAP
Product CodeBYE
Date Received2018-03-09
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerAPRIA HEALTHCARE


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-09

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