MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-08 for ADULT TRACHE DIRECT INTERFACE OPT970 manufactured by Fisher & Paykel Healthcare Ltd.
[119663956]
(b)(4). The opt970 interface is used to deliver humidified oxygen to patients via tracheostomy. The interface is held in place by a neck strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's trache. We followed up with the hospital to sought further information. We were informed that the spo2 of the patient was 98% at the time of the incident and there was no patient injury. Method: the complaint opt970 or the 900pt551 breathing circuit were not returned to fisher & paykel healthcare in (b)(4). Our investigation is based on our knowledge of the product and information provided by the hospital. Results: we were unable to determine the cause of the reported fault. The customer was able to reconnect the circuit and continue the therapy indicates that there was no fault with the complaint device. It is possible that the device was accidentally pulled or the patient was trying to remove the device. Conclusion: the airvo 2 humidifier is designed to deliver humidified high flow therapy which by its nature is an open, non-sealed system. This is quite different to a closed pressure therapy such as non invasive or invasive ventilation. Therefore, the delivered flow is higher than the peak inspiration demand resulting in surplus flow. For a leak to be detected, it must be of a magnitude greater than the normal use, such as completely removing the chamber from the heater plate. The airvo 2 user manual warns the user that: appropriate patient monitoring must be used at all times. The unit is not intended for life support. Our user instructions that accompany the opt970 trache interface state: to ensure loading and movement on tracheostomy tube is kept to a minimum, make sure the lanyard is secured appropriately. Do not crush or stretch tube, to prevent loss of therapy. Appropriate patient monitoring must be used at all times.
Patient Sequence No: 1, Text Type: N, H10
[119663957]
A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that during a routine check of a tracheostomy patient, they noticed the 900pt551 breathing circuit was disconnected from the opt970 tracheostomy interface and the airvo 2 unit was not alarming. The circuit and interface was reconnected by the staff. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2018-00773 |
| MDR Report Key | 7858343 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-08 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-09-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9194534000 |
| 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 TRACHE DIRECT INTERFACE |
| Generic Name | BZA |
| Product Code | BZA |
| Date Received | 2018-09-08 |
| Model Number | OPT970 |
| Catalog Number | OPT970 |
| 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 | 2018-09-08 |