MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-25 for ADULT TRACHE DIRECT INTERFACE OPT970 manufactured by Fisher & Paykel Healthcare Ltd.
[114936166]
(b)(4). The complaint device was not returned to fisher & paykel healthcare (b)(4) for evaluation. The hospital had informed us that the heated breathing tube (hbt) used was an 900pt500, which is used with the f&p airvo heated humidifier. The 900pt500 hbt forms a tight fit with the opt970 interface and requires over 10 newtons of force in order to disconnect it from the interface. The user intsructions (ui) for the airvo 2 system specifically warn that the airvo2 "is not intended for life support" and that "appropriate patient monitoring must be used at all times". The ui also instructs the caregiver to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply. " all optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation. Any product that fails the visual inspection is disposed of. The setup instructions in the user instructions which accompany the opt970 also warn that "appropriate patient monitoring must be used at all times. Failure to monitor the patient may result in loss of therapy, serious injury or death. "
Patient Sequence No: 1, Text Type: N, H10
[114936167]
A nurse reported that two opt970 tracheostomy interfaces are easily detached from the 900pt500 heated breathing tube. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2018-00620 |
| MDR Report Key | 7717329 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-25 |
| Date of Report | 2018-06-25 |
| Date Mfgr Received | 2018-06-25 |
| Date Added to Maude | 2018-07-25 |
| 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 |
| 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 | ADULT TRACHE DIRECT INTERFACE |
| Generic Name | BZA |
| Product Code | BZA |
| Date Received | 2018-07-25 |
| Model Number | OPT970 |
| Catalog Number | OPT970 |
| 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 | 2018-07-25 |