MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-01-27 for ADULT TRACHE DIRECT INTERFACE OPT870 manufactured by Fisher & Paykel Healthcare Ltd.
[65901289]
(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. Method: fisher & paykel healthcare did not receive the complaint opt870 for evaluation, as it was discarded by the customer. Our investigation is based on the information provided by the customer. Results: the customer reported that the opt870 was torn at the tubing. It was further reported that the opt870 tubing was torn by the patient, who uses the opt870 tracheostomy interface at home. It was noted that the device kept getting caught between the customer's chair and the customer kept tugging on it. A lot check was not performed as no lot information was provided. Conclusion: we are unable to confirm the reported complaint, but based on the information provided by the customer, it is likely that the tubing became torn as a result of excessive pulling force being exerted on the device. 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. Device was discarded by the customer.
Patient Sequence No: 1, Text Type: N, H10
[65901290]
A customer in the (b)(6) that an opt870 tracheostomy interface was torn at the corrugated tubing. It was further reported that the opt870 tubing was torn by the patient, who uses the opt870 tracheostomy interface at home. It was noted that the device kept getting caught between the customer's chair and the customer kept tugging on it. No patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2017-00051 |
| MDR Report Key | 6282018 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-01-27 |
| Date of Report | 2016-12-30 |
| Date Mfgr Received | 2016-12-30 |
| Date Added to Maude | 2017-01-27 |
| 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 RAYMOND YAN |
| 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 | 2017-01-27 |
| Model Number | OPT870 |
| Catalog Number | OPT870 |
| 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 LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-27 |