MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-27 for HEATED BREATHING TUBE 900PT531 manufactured by Fisher & Paykel Healthcare Ltd.
[140152182]
(b)(4). The 900pt531 junior heated breathing tube (hbt) is used with the airvo humidifier to deliver warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Method: the complaint 900pt531 hbt was not returned to fisher & paykel healthcare for evaluation. Our investigation is therefore based on our knowledge of the product, information and photographs provided by the customer and previous similar investigations. Results: without the complaint device it is not possible to conclusively determine what caused the reported failure. However, visual inspection of the photographs revealed some deformation in a small section in the centre of the tubing. The tubing had softened and deformed slightly in this section of the limb and small holes had formed. Conclusion: the observed damage is consistent with the tubing having been covered with bedding or similar for a lengthy period of time. The heater wires are coated with teflon, which remains intact even under compressive load and has a much higher melting point than the hbt. During production the heater wires are 100% visually inspected using a camera system. The heater wires are also tested for resistance, continuity, polarity and pitch during production. Before the product leaves the line a full functional test is conducted under load. The airvo system is designed to comply with the electrical safety standard ul60601-1. The case is composed of a flame retardant material. The surface temperature of the heated breathing tube is within the limits specified by iso 8185 with regard to hot tube surface temperature not exceeding 44? Celsius. There are many safety features incorporated into the airvo to prevent overheating and fire. These include: the heater wires in the heated breathing tube are coated with teflon, completely insulating them from the gas path. The pcb at the [patient] end of hose is over moulded with the thermoplastic polymer polypropylene, ensuring it is excluded from the gas path. The airvo contains a transient current detector, tcd. This tcd is tested on the production line. It is also checked by the control system when the airvo is powering up before each use. An 'over-temperature' sensor will automatically cut power to the motor, heater plate and heater wire if it detects any overheating. The airvo is constantly checking power in the heated breathing tube and turns the heater wire off if the measured power is too high. The user instructions that accompany the airvo 2 humidifier include the following warning: adding heat, above ambient levels, to any part of the breathing tube or interface, e. G. Covering with a blanket, or heating it in an incubator or overhead heater for a neonate, could result in serious injury. The user manual instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply. " the user manual also states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases. " and that "the unit is not intended for life support.
Patient Sequence No: 1, Text Type: N, H10
[140152183]
A hospital in (b)(6) reported via a fisher & paykel (f&p) representative that a 900pt531 airvo junior heated breathing tube used with an airvo2 humidifier was found melted. No patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2019-00271 |
| MDR Report Key | 8458755 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-27 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2019-03-27 |
| 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 | 9494534000 |
| 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 | HEATED BREATHING TUBE |
| Generic Name | AIRVO HEATED BREATHING TUBE |
| Product Code | BZE |
| Date Received | 2019-03-27 |
| Model Number | 900PT531 |
| Catalog Number | 900PT531 |
| Lot Number | 140701 |
| 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 | 2019-03-27 |