MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-31 for CPAP PRO manufactured by .
[670092]
I have a cpap pro mask made by stevenson industries inc. The problem i am having is the air hoses keep breaking during sleep. I have had four hoses break in the past three months. I have contacted stevenson industries and their response is they will replace the hoses. There is an obvious design flaw, i have used other masks for over a year with no breaking hoses. I feel this is a very serious problem as i don't like to wake up, do to not breathing, it's not fun.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002450 |
| MDR Report Key | 861121 |
| Date Received | 2007-05-31 |
| Date of Report | 2007-05-31 |
| Date of Event | 2007-05-10 |
| Date Added to Maude | 2007-06-11 |
| 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 | 0 |
| 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 | CPAP PRO |
| Generic Name | CPAP PRO |
| Product Code | NHJ |
| Date Received | 2007-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 845135 |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-31 |