FISHER-PAYKEL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-13 for FISHER-PAYKEL * manufactured by Fisher-paykel Healthcare, Inc..

Event Text Entries

[20163278] Ventilator the pt was on stopped working, pt was bagged and the ventilator was replaced, pt remained stable throughout. Problem stems from the combination of the ventilator, the sensor and the humidifier working in conjunction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1035174
• MDR Report Key: 593017
• Date Received: 2005-04-15
• Date of Report: 2005-04-13
• Date of Event: 2005-03-24
• Date Added to Maude: 2005-04-21
• 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 Sequence Number: 1

• Brand Name: FISHER-PAYKEL
• Generic Name: HUMIDIFIER
• Product Code: BTT
• Date Received: 2005-04-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 582866
• Manufacturer: FISHER-PAYKEL HEALTHCARE, INC.
• Manufacturer Address: 22982 ALCALDE DRIVE SUITE 101 LAGUNA HILLS CA 92652 US

Device Sequence Number: 2

• Brand Name: FISHER-PAYKEL
• Generic Name: VENTILATOR
• Product Code: CBK
• Date Received: 2005-04-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 582868
• Manufacturer: FISHER-PAYKEL HEALTHCARE, INC.
• Manufacturer Address: 22982 ALCALDE DRIVE SUITE 101 LAGUNA HILLS CA 92652 US

Device Sequence Number: 3

• Brand Name: FISHER-PAYKEL
• Generic Name: EXHALATION FLOW SENSOR
• Product Code: BXP
• Date Received: 2005-04-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 582870
• Manufacturer: FISHER-PAYKEL HEALTHCARE, INC.
• Manufacturer Address: 22982 ALCALDE DRIVE SUITE 101 LAGUNA HILLS CA 92652 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-04-15