MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-15 for GOODSMART 420 G-CPAC UNK manufactured by Puritan Bunnett.
[621203]
Patient bought apnea machine from the company. Patient could smell burning plastic when machine was in use and comapny would not take the machine back. Breathing through this device made the patient feel dizzy. This device is faulty and fda needs to do something about it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5001850 |
| MDR Report Key | 847022 |
| Date Received | 2007-04-15 |
| Date of Report | 2007-05-11 |
| Date Added to Maude | 2007-05-21 |
| 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 | GOODSMART 420 G-CPAC |
| Generic Name | APNEA MACHINE |
| Product Code | NPF |
| Date Received | 2007-04-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 837698 |
| Manufacturer | PURITAN BUNNETT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-15 |