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 2020-02-24 for ZOLL IVTM ICY CATHETER 8700-0782-14 IC-3893CO manufactured by Zoll Circulation.
[184387901]
The icy catheter was returned to zoll on (b)(6) 2020 for investigation; however, investigation is still in progress. A supplemental report will be filed when investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[184387902]
After four days, during maintenance phase of 36? C on a patient using ivtm therapy, the user noticed the saline bag was low and air in the tubing. User also observed that the floor was wet. Following this, the saline bag was replaced and re-primed the start-up kit and continued with therapy. After 3 hours during continuation of the maintenance phase of therapy, the user observed an empty saline bag. The user also observed that the condensation tray was full of saline and in the air trap of the ivtm console. Ivtm therapy was discontinued. No consequences or impact to patient. Mfr 3010617000-2020-00196 for thermogard console.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00195 |
| MDR Report Key | 9747574 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-01-14 |
| Date Added to Maude | 2020-02-24 |
| 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 | MS. KIM THOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4192922 |
| Manufacturer G1 | ZOLL CIRCULATION |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOLL IVTM ICY CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | NCX |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-11 |
| Model Number | 8700-0782-14 |
| Catalog Number | IC-3893CO |
| Lot Number | 90398 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION |
| Manufacturer Address | 2000 RINGWOOD AVE. SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |