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 2020-03-06 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[188241772]
The thermogard ivtm console was not returned to zoll for evaluation. Thermogard xp ivtm system was evaluated by zoll service at the customer site. The customer reported issue of thermogard console unable to power on was confirmed during the functional testing. The issue was found to be a blown fuse likely due to the user error. The power supply was switched to the wrong voltage, 115v. After replacing the fuses and setting the power supply power to 230v, the console passed all the testing with no issue or faults observed. All test and readings are within the specified limits and functioned as intended. The fuse is designed to protect the power supply and device from damage when the circuit attempts to draw a greater electrical load than it is intended to carry. This can be caused by, for example, a power supply surge. The tgxp fuse is sized to match the load-carrying capacity of the wires in that device. The fuse is intended to blow before the circuit wires can heat to a dangerous level. Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for thermogard xp ivtm system sn (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188241773]
As reported, during a self-test, the thermogard console (sn (b)(4)) was unable to power on. Another console was used for ivtm therapy. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00224 |
| MDR Report Key | 9800700 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KIMTHOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE, |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4192955 |
| 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 | 2020-03-06 |
| 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 | 2020-03-06 |