MAUDE Adverse Event Report: FISHER PAYKEL FISHER PAYKEL 850 HEATER

Model Number 850

Device Problems Moisture Damage (1405); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2014

Event Type  Injury  

Event Description

Several occurrences of ventilator malfunction with the puritan bennett 760 ventilator while in use with the fisher paykel 850 heater.Error code "call for service" was displayed and ventilator was removed from pt timely no adverse events resulted from these occurrences.Findings: excessive moisture on the internal flow sensor from the fisher paykel 850 heater.

• Brand Name: FISHER PAYKEL 850 HEATER
• Type of Device: HEATER
• Manufacturer (Section D): FISHER PAYKEL
• MDR Report Key: 3610310
• MDR Text Key: 4064382
• Report Number: MW5034187
• Device Sequence Number: 1
• Product Code: BTT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 850
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR