MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-25 for INSPIRATORY/EXPIRATORY FILTER RT019 manufactured by Fisher & Paykel Healthcare Ltd.
[125665558]
(b)(4). The rt019 inspiratory/expiratory filter is a component of the rt380 adult dual heated evaqua2 breathing circuit kit. Method: the complaint rt019 inspiratory/expiratory filter was not returned to fisher & paykel healthcare in (b)(4) for evaluation. An attempt was also made to obtain additional information about the reported fault but no response was received from the customer. Without the return of the complaint filter or further information from the customer, we are unable to determine if the device had a malfunction which could have caused or contributed to the reported event, or identify the root cause of the reported fault. All rt019 inspiratory/expiratory filters are leak tested before releasing for distribution. Any filter which fails the leak test is discarded. The user instructions supplied with the rt380 breathing circuit state: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient. Set appropriate ventilator alarms.
Patient Sequence No: 1, Text Type: N, H10
[125665559]
A hospital in (b)(6) reported that the rt019 inspiratory/expiratory filter was leaking at the saem. The customer stated that there have been multiple events. No patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2018-00917 |
| MDR Report Key | 8007577 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-25 |
| Date of Report | 2018-09-26 |
| Date Mfgr Received | 2018-09-26 |
| Date Added to Maude | 2018-10-25 |
| 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 | INSPIRATORY/EXPIRATORY FILTER |
| Generic Name | CAH |
| Product Code | CAH |
| Date Received | 2018-10-25 |
| 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 | 2018-10-25 |