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

Model Number 82552

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 12/05/2019

Event Type  malfunction  

Event Description

Strong electrical burning smell noticed coming from equipment on standby, plugged in.Smoke noticed coming from equipment.Equipment was unplugged and biomed notified.Equipment labeled and picked up by biomed.Biomed sent equipment to bmes for evaluation/repair.Main cable, heater plate and wire adapter were replaced - calibrated and returned to service.Equipment was not in use by patient at the time.No harm to patient.

• Brand Name: FISHER PAYKEL HEATER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 173 technology drive; suite 100; irvine CA 92618
• MDR Report Key: 10009088
• MDR Text Key: 189323333
• Report Number: 10009088
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 82552
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1