MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-26 for STARDUST 2 manufactured by Respironics/sleep And Homecare Respiratory.
[783379]
If results from last pt study are not manually cleared from memory and the memory is full, when a new pt study is performed, the device allows you to enter pt demographic info for the new pt, but does not record any new test results. When you print out a report, you get the correct pt demographic info, but the results for the study are for the last pt that the device was able to fit into the memory. If the user is not paying close attention, they presume that since the pt identifier info on the printout is correct, that they have the correlating test results on the printout when this is not the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004518 |
| MDR Report Key | 954938 |
| Date Received | 2007-11-26 |
| Date of Report | 2007-11-12 |
| Date Added to Maude | 2007-12-07 |
| 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 | STARDUST 2 |
| Generic Name | PORTABLE SLEEP STUDY SCREENING RECORDER |
| Product Code | LEL |
| Date Received | 2007-11-26 |
| Model Number | STARDUST 2 |
| ID Number | 286112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 927469 |
| Manufacturer | RESPIRONICS/SLEEP AND HOMECARE RESPIRATORY |
| Manufacturer Address | MURRYSVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-26 |