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 2020-03-12 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[188228906]
The reported complaint of "the user observed blown fuse in the thermogard xp ivtm system ((b)(4))" was not confirmed during the functional testing. No device malfunction was observed during the testing and the ivtm system worked as intended. The probable cause for the reported complaint could be due to electrical spike surge. Upon visual inspection, unrelated to the reported complaint, noticed crack on the top cover near the air trap holder and observed discolored (yellow) cold well gasket. The cause for the observed physical damage and cosmetic issue was appeared to be due to user mishandling and/or improper maintenance. The top cover assembly and the cold well gasket were replaced to address the physical damage. The thermogard xp ivtm system passed the functional testing without any error. There was no blown fuse observed during the testing. Following service, the thermogard xp ivtm system passed the final testing without any error.
Patient Sequence No: 1, Text Type: N, H10
[188228907]
During patient treatment, the user observed blown fuse in the thermogard xp ivtm system ((b)(4)). The patient treatment was completed using another ivtm console. No consequences or impact to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00254 |
| MDR Report Key | 9826684 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2017-02-21 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 8700-0650 |
| Catalog Number | 8700-0650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-12 |