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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAPPHIRE EMAR; MEDICAL DEVICE DATA SYSTEM
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SAPPHIRE EMAR; MEDICAL DEVICE DATA SYSTEM Back to Search Results
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2019
Event Type  No Answer Provided  
Event Description
On xx-xx-2019 at approx 1030, i was informed by xx, rn that youth xx had reported to her that he was not given his med (keppra 500mg) last night.Xx, rn reported to this writer that the youth's keppra 500mg 1 tab po bid order did not show up in sapphire emar during the 0730 medpass.However, she was aware of his medication orders and gave him his morning dose.Medical administered to or used by the pt: no.Outcome: however, she was aware of his medication orders and gave him his morning dose.Pt counseling provided: unk.(b)(6).
 
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Brand Name
SAPPHIRE EMAR
Type of Device
MEDICAL DEVICE DATA SYSTEM
MDR Report Key8474042
MDR Text Key140892541
Report NumberMW5085513
Device Sequence Number1
Product Code OUG
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 04/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Patient Sequence Number1
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