MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-02 for ADULT TRACHE DIRECT INTERFACE OPT970E manufactured by Fisher & Paykel Healthcare Ltd.
[91207174]
(b)(4). The opt970e 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 trachea. The complaint opt970e was not returned to fph in (b)(6). Our investigation is accordingly based on the photograph of the subject device that was provided by the healthcare facility. Visual inspection of the photograph revealed that the tubing was disconnected from the manifold. The tubing was also observed to be stretched and partly torn where it had connected to the manifold. Based the photograph, the reported event mostly likely occurred as a result of excessive pulling force being exerted on the device. All optiflow interfaces are inspected during production for visual defects. Any product that fails the visual inspection is rejected. As the subject device had been in use for 2 weeks, this suggests that the reported damage occurred after release for distribution. Our user instructions that accompany the opt970e trachea interface state: to ensure loading and movement on tracheostomy tube is kept to a minimum, make sure the lanyard is secured appropriately. Do not crush or stretch tube, to prevent loss of therapy. Appropriate patient monitoring must be used at all times.
Patient Sequence No: 1, Text Type: N, H10
[91207175]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the tubing of an opt970 tracheostomy interface had detached from the direct connection after 2 weeks of use. No patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2017-01027 |
| MDR Report Key | 6998455 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-05 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-11-02 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON KURUVILLA |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE100 |
| 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 | 2017-11-02 |
| Model Number | OPT970E |
| Catalog Number | OPT970E |
| 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 | 2017-11-02 |