KENDALL CURITY WATER TRAP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-09-02 for KENDALL CURITY WATER TRAP * manufactured by Allegiance Health Care.

Event Text Entries

[17513537] Water trap release valve separated from the main body reservoir, resulting in a loss of inhalation pressure on puritan bennett ventilator.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 185516
• MDR Report Key: 185516
• Date Received: 1998-09-02
• Date of Report: 1998-08-28
• Date of Event: 1998-08-15
• Date Facility Aware: 1998-08-15
• Report Date: 1998-08-28
• Date Reported to FDA: 1998-08-28
• Date Reported to Mfgr: 1998-08-29
• Date Added to Maude: 1998-09-08
• 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
• Reporter Occupation: RISK MANAGER
• 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 Details

• Brand Name: KENDALL CURITY WATER TRAP
• Generic Name: WATER TRAP
• Product Code: BYH
• Date Received: 1998-09-02
• Model Number: *
• Catalog Number: *
• Lot Number: **804298
• ID Number: PART NO. 5275P
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 180327
• Manufacturer: ALLEGIANCE HEALTH CARE
• Manufacturer Address: 1500 WAUKEGAN RD MCGAW PARK IL 60085 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-09-02