MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-11 for RESMED S7 ELITE manufactured by Na.
[15186063]
I went to the offices in 2007 to return their medical equipment to them. They are supposed to be the experts in diagnosis and treatment of sleep apnea. The resmed s7 elite continuous positive airway pressure -cpap- machine i was given to try out for "rental" is not effective. It was not treating my condition any. I kept telling the people at the co that their product was not doing me any good. It was not helping make my sleep apnea any better. I was told on 07/11/07 that they would not accept their medical equipment back for return and that i had to keep the machine. I never signed a purchase agreement with them to purchase the machine. Why should i be made to keep something i told you does not work properly and does not help treat my medical condition? Dates of use:2006 -2007. Diagnosis or reason for use: mild sleep apnea. Event abated after use: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003051 |
| MDR Report Key | 881684 |
| Date Received | 2007-07-11 |
| Date of Report | 2007-07-11 |
| Date of Event | 2007-07-11 |
| Date Added to Maude | 2007-08-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESMED |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2007-07-11 |
| Model Number | S7 ELITE |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 873456 |
| Manufacturer | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-11 |