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 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 nursing staff were not present when the incident occurred and that the patient alerted the nurse that the cannula tubing had disconnected from the part that connects to the breathing circuit.Additionally the customer confirmed that the clothing clip was not being used when the incident occurred.Conclusion: based on the customer statements, we can conclude that the cannula tubing had become disconnected from the distal swivel connector.Failure to use the clothing clip may have placed undue tension on the cannula tubing and led to the disconnection.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.

Event Description

A hospital in (b)(6) reported via a distributor that an opt944 nasal cannula tube became disconnected from the circuit connector during patient use.The patient called the nurse and stated that he did not know how the disconnection had occurred.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: 6313283
• MDR Text Key: 66876995
• Report Number: 9611451-2017-00069
• 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: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• 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