MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. FISHER & PAYKEL; HEATER

Device Problems Smoking (1585); Sparking (2595)

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

Event Date 08/26/2014

Event Type  malfunction  

Event Description

The fisher paykel heater was sparking and smoking.The temperature reading was 37 degrees celsius.

• Brand Name: FISHER & PAYKEL
• Type of Device: HEATER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 15365 barranca pkwy; irvine CA 92618
• MDR Report Key: 4296384
• MDR Text Key: 5192908
• Report Number: 4296384
• Device Sequence Number: 1
• Product Code: BZE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2014
• Patient Sequence Number: 1