CAPNOSTAT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-16 for CAPNOSTAT * manufactured by Zoll.

Event Text Entries

[329673] Etc02 detector did not function on a intubated pt. No wave form present. No etc02 reading present. Verification done per protocol. Etc02 pullled from service and during equipment check was able to duplicate the events. The adapter was sent to internal biomedical engineering dept. New capnostat sent to user and no further problems reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029871
• MDR Report Key: 492283
• Date Received: 2003-10-16
• Date of Report: 2003-10-09
• Date of Event: 2003-08-30
• Date Added to Maude: 2003-10-31
• 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
• Reporter Occupation: RISK MANAGER
• 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: CAPNOSTAT
• Generic Name: MONITOR
• Product Code: CAP
• Date Received: 2003-10-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 480984
• Manufacturer: ZOLL
• Manufacturer Address: 32 SECOND AVE BURLINGTON MA 018034420 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-10-16