MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED OPTIFLOW JR 2 SMALL; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number OJR412

Device Problems Disconnection (1171); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

Respiratory therapy went to assess baby this am.Tubing was disconnected from wiggle/cannula area.Baby not receiving flow.We are unsure what time this took place through the night.At assessment, baby was not in distress, spo2 100% prior to changing the opti flow jr size small.

• Brand Name: OPTIFLOW JR 2 SMALL
• 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: 10815984
• MDR Text Key: 215514875
• Report Number: 10815984
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OJR412
• Device Catalogue Number: 22024669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1