MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-04 for GOODKNIGHT 420G CPAP CPAP G420 M-113900-US manufactured by Talk About Sleep, Inc..
[2896671]
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Patient Sequence No: 1, Text Type: D, B5
[20194452]
In 2007, with doctor's prescription, i ordered "good night 420g cpap" breathing support medical machine for sleep apnea. Six days later, a company delivered the machine; i plugged it in and noticed the "420g cpap" machine constantly turns on/off. It won't keep pressure even if i reduce the air flow by 90%. The machine also smells of burning plastic, and i do not want to be breathing in the smell of burnt plastic. I then called a rep from "talk about sleep" and asked to return the machine back because it does not work properly and it smells of burned plastic. They hung up the phone on me two times, yelled at me, and told me, "no returns; you buy it, it's yours. " this is a medical device; i don't want a device that may be poisonous and get me sick. They sold me a malfunctioned machine which can harm my body; therefore, i want my full refund back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002154 |
| MDR Report Key | 859367 |
| Date Received | 2007-06-04 |
| Date of Event | 2007-05-14 |
| Date Added to Maude | 2007-06-12 |
| 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 |
| 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 | GOODKNIGHT 420G CPAP |
| Generic Name | NONE |
| Product Code | NHJ |
| Date Received | 2007-06-04 |
| Model Number | CPAP G420 |
| Catalog Number | M-113900-US |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 845561 |
| Manufacturer | TALK ABOUT SLEEP, INC. |
| Manufacturer Address | 14480 EWING AVENUE SOUTH SUITE 102 BURNSVILLE MN 55306 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2007-06-04 |