MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-31 for AIRWAY ADAPTER 1103414 manufactured by Respironics Medical Products (shenzhen) Co., Ltd..
Report Number | 9260190 |
MDR Report Key | 9260190 |
Date Received | 2019-10-31 |
Date of Report | 2019-09-12 |
Date of Event | 2019-05-20 |
Report Date | 2019-09-12 |
Date Reported to FDA | 2019-09-12 |
Date Reported to Mfgr | 2019-10-31 |
Date Added to Maude | 2019-10-31 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AIRWAY ADAPTER |
Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
Product Code | BZA |
Date Received | 2019-10-31 |
Catalog Number | 1103414 |
Lot Number | 07111800 |
Device Availability | * |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | RESPIRONICS MEDICAL PRODUCTS (SHENZHEN) CO., LTD. |
Manufacturer Address | 1740 GOLDEN MILE HIGHWAY MONROEVILLE PA 15146 US 15146 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-31 |