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

Model Number RT219

Device Problems Disconnection (1171); Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 01/20/2021

Event Type  Death  

Event Description

Patient in covid isolation precaution room unintentionally disconnected from bipap at mask.Rt responding to the critical event and identified the bipap tubing had been reconnected to the filter and not the mask.Connection points on the exhalation port in the fisher&payke bipap circuit product allows for mask/filter/circuit system to incorrectly assemble.This is easily confused by patient and medical staff that are not trained on circuit set-up.Recommend changing exhalation port to only assemble one way.Manufacture system to visually and physically prevent wrong set-up.Interim fix, hospitals should change out the current exhalation port and replace with a respironics dep w/ filter exhalation port product.

• Brand Name: FISHER PAYKEL HEALTHCARE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER PAYKEL HEALTHCARE LIMITED; 173 technology dr; suite 100; irvine CA 92618
• MDR Report Key: 11412827
• MDR Text Key: 234695211
• Report Number: 11412827
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RT219
• Device Catalogue Number: RT219
• Device Lot Number: 2100863667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death