MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-02-27 for ADULT TRACHE DIRECT INTERFACE OPT870 manufactured by Fisher & Paykel Healthcare Ltd.
[68470770]
(b)(4). The opt870 interface is used to deliver humidified oxygen to patients via tracheostomy. The interface is held in place by a neck strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's trache. The complaint opt870 was not returned to fisher & paykel healthcare (b)(4) for evaluation. Further information was sought from the customer but to date no response has been received. Conclusion: the customer had informed us that the opt870 trache interface disconnected where the tubing meets the connector. Based on this information, it appears likely that the tubing had become disconnected from the swivel that connects to the breathing tube. Without a device for evaluation we cannot determine what has caused the device to malfunction in this way. This is the only complaint of this nature that we have received for the opt870. All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and deformation. Any product that fails the visual inspection is rejected. Our user instructions that accompany the opt870 trache interface state: to ensure loading on tracheostomy tube is kept to a minimum, make sure lanyard is fitted appropriately. Do not crush or stretch tube.
Patient Sequence No: 1, Text Type: N, H10
[68470771]
A hospital in (b)(6) reported that the opt870 tracheostomy interface "often disconnects. " no patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2017-00137 |
| MDR Report Key | 6362759 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-01 |
| Date Mfgr Received | 2017-02-01 |
| Date Added to Maude | 2017-02-27 |
| 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 | MR JON STEVENS |
| Manufacturer Street | 15365 BARRANCA PARKWAY |
| Manufacturer City | IRVINE CA 926182216 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182216 |
| 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 | 2017-02-27 |
| Model Number | OPT870 |
| Catalog Number | OPT870 |
| 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 | 2017-02-27 |