MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD TEMPERATURE/FLOW PROBE; BTT

Model Number 900MR869

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint 900mr869 temperature probe was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Without the return of the complaint device we are unable to determine the root cause of the problem reported by the customer.However, the reported disconnection was most likely due to the temperature probe not properly being inserted into the inspiratory limb port of the rt265 infant breathing circuit.The user instructions that accompany the 900mr869 temperature probe state: - ensure that connectors are firmly plugged into breathing circuit ports before use.Furthermore, the user instructions that accompany the rt265 infant breathing circuit state: · check all connections are tight before use.· perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.· set appropriate ventilator alarms.

Event Description

A hospital in (b)(6) reported that a 900mr869 temperature/flow probe disconnected from the rt265 infant breathing circuit during use.It was further reported that the circuit passed the initial leak test before connecting to a patient and was in use for over a week prior to the probe disconnecting.No patient consequence was reported.

• Brand Name: TEMPERATURE/FLOW PROBE
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7398511
• MDR Text Key: 104733832
• Report Number: 9611451-2018-00266
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900MR869
• Device Catalogue Number: 900MR869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1