MAUDE Adverse Event Report: FISHER PAYKEL HEALTHCARE LIMITED FISHER PAYKEL HEALTHCARE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number MR850JHU

Device Problems No Audible Alarm (1019); Fluid/Blood Leak (1250); Overheating of Device (1437); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

Respiratory therapist went into room noticed that there was puddles of water and that water was spewing out of the heater.The ventilators were switched wasn't completely clear at that time what was causing the issue.Once the ventilator was pulled out of the icu room and cleaned and stripped, the therapist noticed that there was a hole in the cannister where the water goes into that sits on the heater.The heater was not alarming and didn't indicate that it was hotter than normal.Heater was taken off the ventilator.

• Brand Name: FISHER PAYKEL HEALTHCARE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER PAYKEL HEALTHCARE LIMITED; 173 technology dr; irvine CA 92618
• MDR Report Key: 12908099
• MDR Text Key: 281508179
• Report Number: 12908099
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MR850JHU
• Device Catalogue Number: MR850JHU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Sex: Male