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

Model Number OPT942

Device Problems Detachment of Device or Device Component (2907); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A distributor in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the headgear detached from the opt942 nasal cannula during use.No patient consequences were reported.

Manufacturer Narrative

(b)(4).The opt942 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 received at fisher & paykel healthcare and was visually inspected.Results: visual inspection of the returned cannula revealed that the right side of the head strap was detached from the clip.The end of the head strap was taped.After removing the tape, the end of the head strap fabric was found frayed and not smoothly cut.Tape residue was found on the right sleeve of the cannula.After removing the sleeve, no damage was found to the hinge hook and the hinge hook latch was fully engaged.The left side of the head strap was found to be correctly assembled.Conclusion: we are unable to determine how the head strap became detached.This is the only such complaint we have received for the opt900 series cannula in the last 12 months (1 november 2017 to 31 october 2018) out of 1,579,758 units sold worldwide.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 assembly procedure for the opt942 cannula includes clear instructions for assembling the strap to the hinge hook and instructs the assembler to "ensure the hinge hook latches are engaged, using a magnifier".If a hook is found not fully engaged the team leader is notified.The setup instructions in the user instructions which accompany the opt942 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 distributor in france reported via a fisher & paykel healthcare (f&p) representative that the headgear detached from the opt942 nasal cannula during use.No 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: 7950700
• MDR Text Key: 123951580
• Report Number: 9611451-2018-00873
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

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: OPT942
• Device Catalogue Number: OPT942
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 09/13/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1