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 2018-08-28 for INSPIRATORY/EXPIRATORY FILTER RT019 manufactured by Fisher & Paykel Healthcare Ltd.
[118555982]
(b)(4). The complaint rt019 filter has not been received by fisher & paykel healthcare for evaluation. Our investigation is therefore based on the information provided by the customer, our knowledge of the product and previous investigations into similar complaints. Further information was sought from the hospital, and we were informed that exhalation filters are routinely changed once a day and that the drug salbutamol was being nebulised. The rt019 filter is a single use product designed as bacterial/viral filter to prevent contamination by microorganisms present in the ventilatory gases of patients undergoing treatment. From the description of events it does not appear that the device was defective in any way. The occlusion of the filter was most likely due to condensation and the nebulised drugs being administered to the patient. Our user instructions which accompany the rt019 filter state: change every 24 hours or sooner if noticeable deterioration occurs, following standard hospital procedure. When nebulized drugs are used resistance to flow should be monitored and the product replaced, following standard hospital procedure. Our user instructions which accompany the rt266 evaqua2 breathing circuit state: check breathing circuits for condensation every 6 hours and drain if required.
Patient Sequence No: 1, Text Type: N, H10
[118555983]
A hospital in (b)(6) reported via a fisher & paykel healthcare representative that water was observed in the rt019 inspiratory/expiratory filter and it was "exacerbating the patients exhaled work". They further stated that changing the filter resolved the issue. No patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2018-00728 |
| MDR Report Key | 7824442 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-28 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-07-15 |
| Date Mfgr Received | 2018-07-30 |
| Date Added to Maude | 2018-08-28 |
| 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 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 | INSPIRATORY/EXPIRATORY FILTER |
| Generic Name | CAH |
| Product Code | CAH |
| Date Received | 2018-08-28 |
| Model Number | RT019 |
| Catalog Number | RT019 |
| Lot Number | NP |
| 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 | 2018-08-28 |