MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-29 for ADULT NASAL INTERFACE OPT844 manufactured by Fisher & Paykel Healthcare Ltd.
[183335891]
(b)(4). The opt844 interface is used to deliver humidified oxygen to patients. The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface). The interface is held in place by a head 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 nares. Method: the complaint opt844 nasal cannula was not returned to fisher & paykel healthcare for evaluation. Our investigation is thus based on the information and photograph provided by the customer. Result: visual inspection of the photo revealed that the nasal prong was found broken at the left headgear connection point. It was also observed that the manifold and tube was assembled to the wrong side. Conclusion: the damage observed was most likely due to overtightening of the head strap. The opt844 interface may have been disassembled from the manifold and tube and incorrectly reassembled by the caregiver or user. All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation. Any product that fails the visual inspection is disposed of. The subject opt844 nasal cannula would have met the required specification at the time of production. The user instructions which accompany the opt844 cannula show in pictorial format the correct placement and fitting of the cannula and also warn: appropriate patient monitoring must be used at all times. Failure to monitor the patient may result in loss of therapy, serious injury or death. Do not crush or stretch tube.
Patient Sequence No: 1, Text Type: N, H10
[183335892]
A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the connection between the nasal prong and the head strap of opt844 nasal cannula was broken. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00107 |
| MDR Report Key | 9645367 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-29 |
| Date of Report | 2019-12-31 |
| Date Mfgr Received | 2019-12-31 |
| Device Manufacturer Date | 2019-09-05 |
| Date Added to Maude | 2020-01-29 |
| 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 NASAL INTERFACE |
| Generic Name | CAT |
| Product Code | CAT |
| Date Received | 2020-01-29 |
| Model Number | OPT844 |
| Catalog Number | OPT844 |
| Lot Number | 2100872752 |
| 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 | 2020-01-29 |