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 Number: MW5045112
• MDR Report Key: 4974707
• Date Received: 2015-07-31
• Date of Report: 2015-07-31
• Date of Event: 2015-07-23
• Date Added to Maude: 2015-08-05
• 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: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: POWER CHART
• Generic Name: MDDS/EHR
• Product Code: NSX
• Date Received: 2015-07-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CERNER
• Manufacturer Address: KANSAS CITY MO 64117 US 64117

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other	2015-07-31