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 2020-02-28 for ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT RT380 manufactured by Fisher & Paykel Healthcare Limited.
[184119013]
(b)(4). Method: the complaint rt380 evaqua 2 adult breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation. Our investigation is thus based on the information provided by the customer and our knowledge of the product. Results: the customer stated that the tubing of the complaint device was found to have a tear during use. Upon further investigation by the customer, it was found that the device was accidentally cut when opening the boxes where the circuits were stored in. Conclusion: based on the information provided by the customer, the reported event was due to a cut with a sharp object when opening the box with a knife as stated by the customer. All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected. The subject infant breathing circuits would have met the required specifications at the time of production. Our user instructions that accompany the rt380 adult evaqua2 breathing circuit state the following: 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
[184119014]
A healthcare facility in (b)(6) reported that the tubing of a rt380 adult dual heated evaqua2 breathing circuit was found to have a tear during patient use. Further information provided by the healthcare facility the tubing was found to be accidentally cut when opening the boxes where the circuits were stored in. There was no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00214 |
| MDR Report Key | 9767547 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-28 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| 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 LIMITED |
| 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 DUAL HEATED EVAQUA2 BREATHING CIRCUIT |
| Generic Name | BZE |
| Product Code | BZE |
| Date Received | 2020-02-28 |
| Model Number | RT380 |
| Catalog Number | RT380 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |