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 VENTED AUTOFEED HUMIDIFICATION CHAMBER MR290V manufactured by Fisher & Paykel Healthcare Ltd.
[187425043]
(b)(4). Method: the complaint mr290 humidification chamber was not returned to fisher & paykel healthcare for evaluation. Our investigation is based on the information and a photograph provided by the customer. Results: review of the photograph revealed that the water level was above the black water level line. Conclusion: without the return of the complaint device, we were unable to determine what caused the reported event. Overfilling of water is usually caused by both the primary and secondary float mechanisms in the mr290 chamber being disabled. In circumstances where the primary float is disabled, the water may overfill above the black water level line of the chamber but the secondary float will serve as a backup to prevent the water from overflowing outside the chamber port and entering into the breathing circuit. All mr290 chambers have float function and valve testing performed twice during production. A failure of any test would result in rejection of the chamber before distribution. The subject device would have met the specification at the time of production. The user instructions that accompany the mr290 humidification chamber specify in the warning section "do not use the chamber if the water rises above the maximum water level line" along with a diagram directing the user to check the water level on the chamber. A written description of the meaning of the symbols used is also included in the user instructions. It also states the following: "set appropriate ventilator alarm. " "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient. "
Patient Sequence No: 1, Text Type: N, H10
[187425045]
A distributor in (b)(6) reported on behalf of a healthcare facility to a fisher & paykel healthcare (f&p) field representative that an mr290v vented autofeed humidification chamber was overfilled immediately during normal use. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00329 |
| MDR Report Key | 9881854 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-07-04 |
| 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 DR. 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 | VENTED AUTOFEED HUMIDIFICATION CHAMBER |
| Generic Name | AUTOFEED CHAMBER |
| Product Code | BTT |
| Date Received | 2020-03-26 |
| Model Number | MR290V |
| Catalog Number | MR290V |
| Lot Number | 190704 |
| 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 | 2020-03-26 |