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 THERMOGARD XP 8700-0650 8700-0650-12 manufactured by Zoll Circulation.
[184387905]
An onsite evaluation of the thermogard xp ivtm console (sn (b)(4)) was performed by a zoll service technician. No device malfunction was observed during testing. Ivtm console performed as intended. During visual inspection, corrosion was observed on the cooling engine compressor hold-down bold. This observation does not affect system performance of the console and not related to the reported complaint. A review of the event log was performed and no issues were observed. The thermogard console passed all testing and is certified for routine clinical use.
Patient Sequence No: 1, Text Type: N, H10
[184387906]
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 3010617000-2020-00195 for icy catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00196 |
| MDR Report Key | 9748268 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2016-11-18 |
| 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 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 THERMOGARD XP |
| Generic Name | THERMAL REGULATING SYSTEM |
| Product Code | NCX |
| Date Received | 2020-02-24 |
| Model Number | 8700-0650 |
| Catalog Number | 8700-0650-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |