INVIVO/MDE CARDIAC MONITOR 20403 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-15 for INVIVO/MDE CARDIAC MONITOR 20403 * manufactured by Invivo Research, Inc..

Event Text Entries

[402709] The patient was seen in the ed with respiratory failure and was intubated and placed on the cardiac monitor. The nurse entered the patient's room and found the patient in asystole with no audio alarms from the monitor in the room or the central monitoring station. After reviewing the strip, the patient had been in asystole for several minutes. It was later determined that the bedside monitor alarms could be turned off at the central monitor and that the alarms do not reset to the audible position between patients. It was also noted that the audible alarm at the central monitoring system was too low to be heard in a busy area.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 593240
• MDR Report Key: 593240
• Date Received: 2005-03-15
• Date of Report: 2005-03-15
• Date of Event: 2005-02-04
• Report Date: 2005-03-15
• Date Reported to FDA: 2005-03-15
• Date Added to Maude: 2005-04-21
• 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: INVIVO/MDE CARDIAC MONITOR
• Generic Name: CARDIAC MONITOR
• Product Code: DRT
• Date Received: 2005-03-15
• Model Number: 20403
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 4 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 583084
• Manufacturer: INVIVO RESEARCH, INC.
• Manufacturer Address: 12601 RESEARCH PARKWAY ORLANDO FL 32826 US
• Baseline Brand Name: *
• Baseline Generic Name: CARDIAC MONITOR
• Baseline Model No: 20403
• Baseline Catalog No: *
• Baseline ID: *

Device Sequence Number: 2

• Brand Name: VISION
• Generic Name: CENTRAL MONITOR
• Product Code: MLD
• Date Received: 2005-03-15
• Model Number: 136416
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 583085
• Manufacturer: INVIVO RESEARCH, INC.
• Manufacturer Address: 12601 RESEARCH PARKWAY ORLANDO FL 32826 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2005-03-15