NELLCOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-06 for NELLCOR * manufactured by Tyco Healthcare Group Lp, Nellcor Puritan Bennett Division.

Event Text Entries

[420389] On at least two occasions rptr has encountered a problem while using the nellcor pedi-cap co2 detector. When the pedi-cap is used with a nrpr (non-rebreaathing pressure relieving bag) and healthcare personnel want to change connection between mask and ett, the connector male of the pedi-cap sticks, and in some cases, breaks off in the female portion of the nrpr rendering the bag unusable. If another device is not readily available the pt would be in jeopardy. Rptr has encountered this sticking problem with both cardinal and vent labs nrpr bags.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1037672
• MDR Report Key: 663561
• Date Received: 2006-01-06
• Date of Report: 2006-01-06
• Date of Event: 2005-12-17
• Date Added to Maude: 2006-01-17
• 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: NELLCOR
• Generic Name: PEDI-CAP CO2 DETECTOR
• Product Code: CCL
• Date Received: 2006-01-06
• Model Number: *
• Catalog Number: *
• Lot Number: 5311075
• ID Number: *
• Device Expiration Date: 2008-11-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 652982
• Manufacturer: TYCO HEALTHCARE GROUP LP, NELLCOR PURITAN BENNETT DIVISION
• Manufacturer Address: * PLEASANTON CA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2006-01-06