SAPPHIRE EMAR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for SAPPHIRE EMAR manufactured by Unk.

Event Text Entries

[140892541] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085513
MDR Report Key8474042
Date Received2019-04-01
Date of Report2019-04-01
Date of Event2019-01-01
Date Added to Maude2019-04-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSAPPHIRE EMAR
Generic NameMEDICAL DEVICE DATA SYSTEM
Product CodeOUG
Date Received2019-04-01
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-01

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