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

Model Number OPT846E

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint opt846e nasal cannula was not returned to fisher & paykel healthcare (b)(4) for evaluation.Our investigation is based on the visual inspection of a photograph of the complaint cannula, showing the damage.Result: visual inspection of the provided photograph revealed that the soft silicone part on the left side of the nasal interface had been torn apart.The complaint cannula appeared soiled and well used.Conclusion: the cannula would not have passed testing on the production line in a damaged condition.Previous investigations into this type of damage have shown that the most likely cause is overtightening of the headstrap while adjusting it.An excessive amount of force would be required to tear the interface.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The user instructions which accompany the optiflow cannula contain the following warning: - do not crush or stretch tube.The user instructions also show in pictorial format the correct placement and fitting of the cannula.

Event Description

A healthcare facility in (b)(6) reported that a home patient's opt846e nasal cannula broke after a week of use.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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 6190502
• MDR Text Key: 62916199
• Report Number: 9611451-2016-00895
• 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: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2016

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: Lay User/Patient
• Device Model Number: OPT846E
• Device Catalogue Number: OPT846E
• Device Lot Number: 150226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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