CERNER BRIDGE MEDICAL MEDPOINT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-25 for CERNER BRIDGE MEDICAL MEDPOINT * manufactured by Cerner Corporation.

Event Text Entries

[21787212] During a medication pass, the bar code scanner failed and the nurse was unable to scan the patient's id/medication. The device failed and there was not enough time to troubleshoot or reset the device. The medication had to be given stat and the error occurred when the scanner failed and the rn wasn't able to verify that the wrong dose was being given to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1250243
• MDR Report Key: 1250243
• Date Received: 2008-11-25
• Date of Report: 2008-11-25
• Date of Event: 2008-10-14
• Report Date: 2008-11-25
• Date Reported to FDA: 2008-11-25
• Date Added to Maude: 2008-12-04
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CERNER BRIDGE MEDICAL MEDPOINT
• Generic Name: MEDICATION ADMINISTRATION SYSTEM
• Product Code: NZH
• Date Received: 2008-11-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 1303579
• Manufacturer: CERNER CORPORATION
• Manufacturer Address: 2800 ROCKCREEK PARKWAY KANSAS CITY MO 64117 US

Device Sequence Number: 2

• Brand Name: BT FOCUS SCANNER WITH 9535 CRADLE
• Generic Name: BAR CODE SCANNER
• Product Code: NZH
• Date Received: 2008-11-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 4 YR
• Implant Flag: *
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 1303580
• Manufacturer: HONEYWELL, METROLOGIC DIVISION
• Manufacturer Address: CORPORATE HEADQUARTERS 90 COLES ROAD BLACKWOOD NJ 080124683 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-11-25