MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-14 for S8 VANTAGE AUTO CORE manufactured by Resmed.
[2408919]
The cpap i use for my sleep apnea just shuts off while in use. The sudden lack of air flow and subsequent difficulty wake me up. This happened two times on the evening of (b)(6) 2012. This has happened before multiple times and when i contact the dme company they cannot or will not help. The last incident was (b)(6) 2012. I have had at least two different nights when the machine shut off more than 4 times during the night. At first i thought it was a power problem (ie dirty power) because it seemed to happen mostly when i was away from home. It is always plugged into a surge protector- but i began using a surge protector away from home and the problem persisted and began happening at home also. This problem not only disrupts my sleep but i worry that one day the sudden lack of air will not wake me up and this device malfunction may contribute to or cause suffocation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024668 |
| MDR Report Key | 2495937 |
| Date Received | 2012-03-14 |
| Date of Report | 2012-03-14 |
| Date of Event | 2012-03-13 |
| Date Added to Maude | 2012-03-22 |
| 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 | S8 VANTAGE AUTO CORE |
| Generic Name | CPAP |
| Product Code | BYE |
| Date Received | 2012-03-14 |
| Model Number | S8 VANTAGE AUTO CORE |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2012-03-14 |