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

Model Number OPT944

Device Problem Device Handling Problem (3265)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/25/2017

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.The complaint cannula was not returned to fisher & paykel healthcare for evaluation but has been retained by the hospital.Our investigation is based on the information provided by the hospital.The hospital informed us that a patient on nasal high flow therapy was noted to be de-saturating.The therapist went in to assess the patient and found the large tubing leading to the prongs was turned, blowing the o2 away from the patient.The hospital also provided a photograph showing the prongs incorrectly oriented.The prongs are designed to be able to turned for positioning on either side of patient's face for comfort.The hospital further confirmed that there was no malfunction of the cannula itself.Additional training was immediately carried out to ensure staff were aware of how to position the prongs.It was also noted by the hospital that "the family had been 'fussing' with" the cannula" prior to the incident.Once the cannula was positioned correctly there were no further problems.This is the only complaint of this nature that we have received for the opt900 series cannula.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 show in pictorial format the correct setup of the cannula and prongs and includes 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 caution: failure to use the set-up described above can compromise performance and affect patient safety.Kept by hospital.

Event Description

A hospital in (b)(6) reported that a patient desaturated while using an opt944 nasal cannula.It was then found that staff had incorrectly placed the prongs the wrong way around, with flow directed away from the patient.The prongs were repositioned and there was no further patient consequence reported.

• 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: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 6419813
• MDR Text Key: 70458690
• Report Number: 9611451-2017-00219
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• 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
• Date Manufacturer Received: 02/20/2017
• 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