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 2020-03-24 for VENTED HUMIDIFICATION CHAMBER 900PT290E manufactured by Fisher & Paykel Healthcare Ltd.
[187432926]
(b)(4). Method: the complaint 900pt290e humidification chamber was not returned to fisher & paykel healthcare in (b)(4) for investigation. Our investigation is thus based on the information and photographs provided by the customer. Results: visual inspection of the provided photograph revealed no visible damage to the chamber. Conclusion: we are unable to confirm the reported event. Every 900pt290e 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.
Patient Sequence No: 1, Text Type: N, H10
[187432927]
A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel healthcare (f&p) field representative that the 900pt290e humidification chamber was leaking from the base. There was no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00311 |
| MDR Report Key | 9876209 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-24 |
| 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 | 7923912142 |
| 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 HUMIDIFICATION CHAMBER |
| Generic Name | AUTOFEED CHAMBER |
| Product Code | BTT |
| Date Received | 2020-03-24 |
| Model Number | 900PT290E |
| Catalog Number | 900PT290E |
| Lot Number | NOT PROVIDED |
| 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 | 2020-03-24 |