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

Model Number OPT942

Device Problems Leak/Splash (1354); No Apparent Adverse Event (3189)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint opt942 interface is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A customer in (b)(6) reported that the opt942 nasal cannula was leaking after 4 days of use, causing reddening of the patient's skin.No further patient consequences were reported.

Manufacturer Narrative

Ps299579 method: the complaint opt942 interface was received at fisher & paykel healthcare in new zealand for evaluation.A visual inspection of the opt942 cannula was performed.Results: visual inspection revealed no damage to any part of the returned nasal cannula.Conclusion: we were unable to determine what may have caused the reported leak as no fault was found with the returned device.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.From the information provided by the customer, it is possible that one side of the nasal prongs became partly detached from the manifold.If the prongs are only partially detached, it is likely that they can be moved back into position due to movement (e.G.During transport).The user instructions that accompany the opt942 interface show the correct placement of the nasal prongs on the manifold, as well as the correct use of the white headstrap clip and the blue clothing clip.In addition, 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 customer in the uk reported that the opt942 nasal cannula was leaking after 4 days of use, causing reddening of the patient's skin.No further patient consequences were 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
• MDR Report Key: 8340991
• MDR Text Key: 137836051
• Report Number: 9611451-2019-00118
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OPT942
• Device Catalogue Number: OPT942
• Device Lot Number: 2100508787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1