MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. MR850 RESPIRATORY HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/11/2017

Event Type  malfunction  

Event Description

The fisher-paykel 850 ventilator heater was alarming even after changing out heater wires and troubleshooting.Heater was tested by biomedical department and subsequently exchanged.

• Brand Name: MR850 RESPIRATORY HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 173 technology dr.; irvine CA 92618
• MDR Report Key: 6773233
• MDR Text Key: 82030928
• Report Number: 6773233
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2017,08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2017
• Event Location: Home
• Date Report to Manufacturer: 07/31/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Age: 7 YR
• Patient Weight: 4