STARDUST 2
Received Nov 26, 2007
Report MW5004518 · MDR key 954938
Device
Generic name
Portable Sleep Study Screening Recorder
Manufacturer
Respironics/sleep And Homecare RespiratoryModel number
STARDUST 2Product problems
- Computer Software Problem
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
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.