MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-26 for ADULT NASAL INTERFACE OPT944 manufactured by Fisher & Paykel Healthcare Ltd.
[187890175]
(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. Method: the complaint cannula was not received at fisher & paykel healthcare for evaluation. Our investigation is thus based on the photographs provided by the customer. Results: visual inspection of the provided photograph revealed that the cannula was detached from the swivel connector. Photograph provided shows no signs of stretched tube. Conclusion: with the information available, we were unable to conclusively determine the cause of the reported event. 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. "
Patient Sequence No: 1, Text Type: N, H10
[187890176]
A distributor in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow adult nasal cannula was split near the circuit connector. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00328 |
| MDR Report Key | 9881840 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-11-18 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4534000142 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT NASAL INTERFACE |
| Generic Name | CAT |
| Product Code | CAT |
| Date Received | 2020-03-26 |
| Model Number | OPT944 |
| Catalog Number | OPT944 |
| Lot Number | 2100940735 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |