MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2018-06-18 for HME TYPE I ADULT 003003-A manufactured by Amsino Medical Group Hong Kong Co Ltd.
[111427505]
Vyaire has reached out to customer to provide the complaint device for further investigation. At this time we are currently waiting for verification that the sample will be available. If we receive any additional information or the device for further evaluation vyaire will provide a follow up emdr.
Patient Sequence No: 1, Text Type: N, H10
[111427506]
The customer reported that the heat and moisture exchanger (hme) filter is coming apart at the seam. Airflow could be felt and heard. Failure occurred during patient use with no report of patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-2018-00116 |
| MDR Report Key | 7612145 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-04-07 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2018-06-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVERY FOSTER |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | AMSINO MEDICAL GROUP HONG KONG CO LTD |
| Manufacturer Street | 708 CORPORATE CENTER DRIVE |
| Manufacturer City | POMONA CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HME TYPE I ADULT |
| Generic Name | CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) |
| Product Code | BYD |
| Date Received | 2018-06-18 |
| Catalog Number | 003003-A |
| Lot Number | J1017015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMSINO MEDICAL GROUP HONG KONG CO LTD |
| Manufacturer Address | 708 CORPORATE CENTER DRIVE POMONA 91768 US 91768 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-18 |