POWER CHART

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for POWER CHART manufactured by Cerner.

Event Text Entries

[23535391] An outpatient was ordered to have an ultrasound guided aspiration of a chronic fluid collection in the deep muscles of the hip area that was tracking via fistula cutaneously. Cultures and chemistries of the fluid were ordered by the outpatient doctor and sent by the radiology team to the lab. Ten days passed and none of the results were received by the ordering physician. It was discovered that when the pt presented for f/u, that the results were in the ehr mdds device, but no one knew. The radiologist was not expected to search for the results, nor were the results sent to the radiologist of the ordering physician. The results were in one of the silos in the ehr but there was not any warning, notification, or reconciliation that results were not received by the ordering doctor who did not have access to this hospital's ehr. The abscess grew a virulent organism. The treatment was delayed by the failure of the device to deliver the results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5045112
MDR Report Key4974707
Date Received2015-07-31
Date of Report2015-07-31
Date of Event2015-07-23
Date Added to Maude2015-08-05
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 NamePOWER CHART
Generic NameMDDS/EHR
Product CodeNSX
Date Received2015-07-31
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCERNER
Manufacturer AddressKANSAS CITY MO 64117 US 64117


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 2015-07-31

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