MAUDE Adverse Event Report: TUBING ASSEMBLY INFANT RESP O2 30/CS; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number TUBING ASSEMBLY INFANT RESP O2 30/CS

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

The sample was not returned for evaluation.Therefore the defect reported by the customer cannot be confirmed and no root cause could be determined.Any additional information received from the customer will be included in a follow up report.

Event Description

The customer reported that the tubing assembly infant respiratory care does not fit in the fisher & paykel infant optiflow circuit.The customer confirmed that there was a delay in patient care but it did not result in patient injury or harm.

Manufacturer Narrative

Device evaluation: g4, h2, h3, h6 and h10.H10: the device history record review show no deviations to manufacturer specification.The sample was not returned for evaluation.Therefore the defect reported by the customer cannot be confirmed and no root cause could be determined.

• Brand Name: TUBING ASSEMBLY INFANT RESP O2 30/CS
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• MDR Report Key: 9771556
• MDR Text Key: 188823890
• Report Number: 8030673-2020-00086
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 10190752102903
• UDI-Public: (01)10190752102903(11)20190711(10)0004104917,(01)10190752102903(11)20190626(10)0004102069
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TUBING ASSEMBLY INFANT RESP O2 30/CS
• Device Catalogue Number: 5550-504
• Device Lot Number: 0004102069, 0004104917
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1