MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT

Model Number OPT944

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt944 interface is used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint cannula was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on information provided by the customer.We were informed that the incident occurred while the patient was being turned/repositioned and that the tubing may have been pulled during this time.The customer also stated that the humidifier was a 'fair distance' from the bed so the tubing may have been stretched during nursing care.Additionally the customer confirmed that the clothing clip was not being used at all times.Conclusion: based on the customer statements, we can conclude that the cannula tubing had become disconnected from the distal swivel connector due to undue stress being placed on it as a result of its distance from the humidifier and excessive stretching during patient care.It must also be noted that the cannula had already been in use for 3-4 days, which indicates that it was functioning correctly prior to the incident.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.The setup instructions in the user instructions which accompany the opt944 nasal cannula include the following steps: ensure head strap clip is attached, to prevent cannula from being pulled out of the nares; cannula can become unattached if not used with the head strap clip; attach tubing clip to clothing/bedding to prevent cannula from pulling off face.The user instructions also contain the following warnings/cautions: do not crush or stretch tube, to prevent loss of therapy; failure to use the set-up described above can compromise performance and affect patient safety.A fisher & paykel healthcare representative has reiterated the importance of using the clothing clip and offered to provide further in-service training for the hospital staff.

Event Description

A hospital in (b)(6) reported that an opt944 nasal cannula tube disconnected from the swivel while on a patient.There was no patient consequence.

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: CAT
• 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: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 6123490
• MDR Text Key: 60763506
• Report Number: 9611451-2016-00789
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2016

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: OPT944
• Device Catalogue Number: OPT944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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