MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL CPAP BREATHING CIRCUIT; BTT

Model Number RT139

Device Problems Loose or Intermittent Connection (1371); Obstruction of Flow (2423); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt139 bi-level/cpap circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in the united kingdom reported via a fisher and paykel healthcare (f&p) field representative that an rt139 bi-level cpap circuit was obstructed and the elbow was loose.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) bi-level/cpap circuit was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected.Results: visual inspection of the returned rt139 circuit revealed that the red circuit label was found inside the tube next to the elbow connector.It was further noted that the elbow connector was found fully attached to the tube and the patient end connector was found partly detached.No damage was found to the tube or the connectors.Conclusion: based on the information provided by the customer and the results of the investigation, it is likely that the red circuit label was accidentally pushed inside the tube when reassembling the elbow connector to the tube.We are unable to determine the cause of loose connection however, it is possible that the caregiver accidentally pulled the connector when draining the circuit.All rt139 bi-level/cpap circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt139 bi-level/cpap circuit state the following: - "check all connections are tight before use." - "check for occlusions in both inspiratory and pressure line before connecting to patient." - "before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed.".

Event Description

A healthcare facility in the united kingdom reported via a fisher and paykel healthcare (f&p) field representative that an rt139 bi-level cpap circuit was obstructed and the elbow was loose.There was no patient consequence.

• Brand Name: BI-LEVEL CPAP BREATHING CIRCUIT
• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14079114
• MDR Text Key: 295336992
• Report Number: 9611451-2022-00343
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT139
• Device Catalogue Number: RT139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1