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

Model Number RT219

Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

Patient was on rescue cpap (continuous positive airway pressure therapy) through v60 with rt219 circuit.Settings of cpap of 12 and 100% fio2.Patient became disconnected and was reconnected by an unknown person or self incorrectly to the filter.Patient desaturated to 21% and required emergent intubation and transfer to icu level of care.

• 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: 11670317
• MDR Text Key: 245587689
• Report Number: 11670317
• 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: 04/07/2021,03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RT219
• Device Catalogue Number: RT219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1