MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-05 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[186584966]
An onsite evaluation of the thermogard xp ivtm console (sn (b)(4)) was performed by a zoll service technician. The report of the thermogard console was slow to cool was confirmed during functional testing. The root cause is due to a dirty air filter and dirty tank due to lack of preventive maintenance. Upon visual inspection, tank and air filter was dirty. Unrelated to the reported complaint, the console's coldwell cap assembly and drip pan was missing. A review of the event log was performed and no issues were observed. After service and replacing air filter, coldwell cap assembly and drip pan, the console passed all testing criteria and meets performance specifications. Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for the thermogard console with serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186584968]
The thermogard console (sn (b)(4)) was slow to cool. The reporter was unable to specify if the issue occurred during device check or patient use. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00228 |
| MDR Report Key | 9794345 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2016-07-07 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Model Number | 8700-0650 |
| Catalog Number | 8700-0650 |
| 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 | 2020-03-05 |