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 2020-03-24 for INSPIRATORY/EXPIRATORY FILTER RT019 manufactured by Fisher & Paykel Healthcare Ltd.
[187782162]
(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 returned to fisher & paykel healthcare (f&p) in (b)(4) for investigation, where it was visually inspected and pressure tested. Results: visual inspection revealed no visible damage to the returned filter. The pressure test revealed that the subject filter was out of specification. The filter was found leaking at the welding line. Conclusion: we were unable to determine the cause of the reported event. All rt019 inspiratory/expiratory filters are leak tested before releasing for distribution. Any filter which fails the leak test is discarded. The subject rt019 would have met the required specifications at the time of production. 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
[187782183]
A distributor on behalf of a healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a rt380 adult dual-heated evaqua2 breathing circuit failed a ventilator leak test before use. After changing the rt019 inspiratory/expiratory filter used with the circuit, the rt380 circuit passed the test. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00296 |
| MDR Report Key | 9876056 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-24 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FARANAK GAMAROONI |
| 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 | INSPIRATORY/EXPIRATORY FILTER |
| Generic Name | CAH |
| Product Code | CAH |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-18 |
| Model Number | RT019 |
| Catalog Number | RT019 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-24 |