SENSORMEDICS METABOLIC CART *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-21 for SENSORMEDICS METABOLIC CART * manufactured by Sensormedics.

Event Text Entries

[409124] As part of a trial, rptr believes they have identified a systematic problem with certain models of a sensormedics metabolic cart which seem to be consistently producing low oxygen consumption (vo2) readings and as you know, this can have a dramatic influence on the care pathway for pts with advanced heart failure. Rptr has had a preliminary meeting with the co and is now in the process of sending them a formal notification of the potential problem. However, due to the gravity and widespread nature of the problem they also feel that they have a responsibility to notify the fda device office immediately as the problem is being sorted out. Rptr now has a formal draft of the notification letter and some validation data which support the fact that there is likely a systematic device malfunction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034977
• MDR Report Key: 583998
• Date Received: 2005-03-21
• Date Added to Maude: 2005-03-24
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SENSORMEDICS METABOLIC CART
• Generic Name: *
• Product Code: BZC
• Date Received: 2005-03-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 573824
• Manufacturer: SENSORMEDICS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-03-21