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 2020-03-26 for ADULT NASAL INTERFACE OPT844 manufactured by Fisher & Paykel Healthcare Ltd.
[185176051]
Ps335242. The complaint opt844 nasal cannula and 900pt501 heated breathing tube are currently en route to fisher & paykel healthcare (f&p) new zealand for evaluation to determine if f&p's products caused or contributed to the reported event. We will provide a follow up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[185176052]
A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a patient with interstitial lung disease was found unconscious. It was reported that an opt844 optiflow nasal cannula was found disconnected from a 900pt501 heated breathing tube. It was further reported that the patient deceased after few days of the event. It was also reported that a "vital sign monitor" (biological monitoring device; non f&p device) was on the patient however it did not work as expected at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00321 |
| MDR Report Key | 9887140 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4534000142 |
| 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 | 2020-03-26 |
| Model Number | OPT844 |
| Catalog Number | OPT844 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Death; 2. Other | 2020-03-26 |