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 2020-03-28 for AIRVO2 HUMIDIFIER PT101 manufactured by Fisher & Paykel Healthcare Ltd.
[187891663]
(b)(4). Method: the complaint airvo humidifier was received at our fisher & paykel healthcare (f&p) regional office in (b)(4) and was inspected by a trained f&p technician. The device was performance tested and the audible alarm function was checked. Results: during testing, no audible alarm was heard. The fault was traced to a faulty speaker and electrical resistance testing showed that the speaker's resistance was open circuit. Conclusion: as part of our ongoing product improvement initiatives, we have implemented a soak test for 100% testing of the speaker harness on the airvo production line, which identifies and discards any faulty speakers prior to assembly into the airvo. Additionally, a new speaker unit has more recently been sourced from a different supplier. The subject airvo was manufactured prior to implementation of the new speaker. The airvo user manual states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases. " and that "the unit is not intended for life support. " the user manual warns the user: prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section. The alarm system functionality check instructs the user on how to check the alarm and states that "if either alarm signal is absent, do not use the unit. Contact your fisher & paykel healthcare representative. "
Patient Sequence No: 1, Text Type: N, H10
[187891664]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier was faulty. Upon device assessment the speaker of the pt101 humidifier was found to be faulty. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00332 |
| MDR Report Key | 9892461 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-28 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2016-01-12 |
| Date Added to Maude | 2020-03-28 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | AIRVO2 HUMIDIFIER |
| Generic Name | AIRVO2 HUMIDIFIER |
| Product Code | BTT |
| Date Received | 2020-03-28 |
| Model Number | PT101 |
| Catalog Number | PT101 |
| Lot Number | 21000111659 |
| 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 | 2020-03-28 |