MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for CURITY 9570E manufactured by Kendall Gammatron, Thailand.
[187559677]
This product is not sold in us and is 510(k) exempt. This report is associated to a similar product sold in the us with 510(k) number k892432. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187559678]
According to the reporter, after insertion into the airway and connection to the ventilator for a period of time, there was an alarm and the device had a leakage. After reintubation, there was no alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040459-2020-00016 |
| MDR Report Key | 9874031 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-07-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | KENDALL GAMMATRON, THAILAND |
| Manufacturer Street | NAKHON CHAI SI DISTRICT |
| Manufacturer City | NAKHON PATHOM |
| Manufacturer Country | TH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURITY |
| Generic Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-24 |
| Model Number | 9570E |
| Catalog Number | 9570E |
| Lot Number | 1918209FED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KENDALL GAMMATRON, THAILAND |
| Manufacturer Address | NAKHON CHAI SI DISTRICT NAKHON PATHOM TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |