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 2020-03-22 for VENTED AUTOFEED HUMIDIFICATION CHAMBER MR290V manufactured by Fisher & Paykel Healthcare Limited.
[187431422]
(b)(4). Method: the complaint mr290v humidification chambers were not returned to fisher & paykel healthcare for evaluation. The investigation is thus based on the photography, videography and information provided by the customer, and our knowledge of the product. Results: visual inspection of the photography and videography provided by the customer revealed a crack at the chamber dome and water leak. Conclusion: we are unable to determine what had caused the cracking on the chamber dome. Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes. Any chamber which fails this test is rejected. In addition, the pressure test is followed by a visual inspection of each chamber. No cracks in the chamber dome are acceptable. Any chamber that fails this inspection is rejected. The subject mr290v chambers would have met the required specification at the time of production. Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: "do not soak, wash, sterilize, or reuse this product. Avoid contact with chemicals, cleaning agents, or hand sanitizers. " "set appropriate ventilator alarms. " "perform a pressure and leak test on the breathing system and check. "
Patient Sequence No: 1, Text Type: N, H10
[187431523]
A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the mr290v vented autofeed humidification chambers were leaking water near the chamber base after few days of use. There were no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00304 |
| MDR Report Key | 9863696 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-22 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-08-09 |
| Date Added to Maude | 2020-03-22 |
| 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 LIMITED |
| 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 | BTT |
| Product Code | BTT |
| Date Received | 2020-03-22 |
| Model Number | MR290V |
| Catalog Number | MR290V |
| Lot Number | 190719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-22 |