MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-02 for HME TYPE I ADULT 003003 manufactured by Amsino Medical Group Hong Kong Co Ltd.
[107152202]
It has been confirmed by vyaire that the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. If a sample or any additional information becomes available a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[107152203]
Customer reported "i have had an heat and moisture exchanger (hme) come apart while disconnecting a patient from the vent. We were changing out an endotracheal tube (ett). Customer confirmed the hme "came apart while removing; no harm done".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-2018-00102 |
| MDR Report Key | 7480861 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-02 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-03-31 |
| Date Mfgr Received | 2018-06-19 |
| Date Added to Maude | 2018-05-02 |
| 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 | KRISTIN GRAF |
| 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 | NO. 355 HUAZHE RD SONGJIANG EXPORT PROCESSING ZONE |
| Manufacturer City | SHANGHAI 201613 |
| Manufacturer Country | CH |
| 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 | 2018-05-02 |
| Catalog Number | 003003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMSINO MEDICAL GROUP HONG KONG CO LTD |
| Manufacturer Address | NO. 355 HUAZHE RD SONGJIANG EXPORT PROCESSING ZONE SHANGHAI 201613 CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-02 |