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 2018-06-13 for HME TYPE I ADULT 003003 manufactured by Amsino Medical Group Hong Kong Co Ltd.
[110995032]
Customer advocacy has reached out to customer to provide sample for the investigation. Ups label was provided to the customer. At this time, we are currently waiting for the sample. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.
Patient Sequence No: 1, Text Type: N, H10
[110995033]
The customer reported that the heat and moisture exchanger (hme) filter is coming apart at the seam. The customer reported that the filter did break apart during use. "the ventilator alarm alerted us to the problem".
Patient Sequence No: 1, Text Type: D, B5
[114578635]
Malfunction was not checked on the initial submission that has been corrected in this supplemental.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050001-2018-00112 |
| MDR Report Key | 7598407 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-04-07 |
| Date Mfgr Received | 2018-07-06 |
| Date Added to Maude | 2018-06-13 |
| 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 | 2018-06-13 |
| Returned To Mfg | 2018-06-26 |
| Catalog Number | 003003 |
| Lot Number | J1017015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMSINO MEDICAL GROUP HONG KONG CO LTD |
| Manufacturer Address | 708 CORPORATE CENTER DRIVE POMONA CA 91768 US 91768 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-13 |