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 2020-03-09 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[188220751]
An onsite evaluation of the thermogard xp ivtm console (sn (b)(4)) was performed by a zoll service technician. The reported complaint of a tcmid: 05 (coolant diff failure) was not observed during functional testing; however was confirmed during review of the event log. The probable root cause was due to the damaged lm 34 temperature sensor and damaged pic 16 board likely due to normal wear and tear of the console. The thermogard xp ivtm console is a reusable device and was manufactured on 30 october 2011. It has exceeded its expected serviceable life of five years and is over 8 years old. Upon visual inspection no physical damage was observed. A review of the event log was performed and several tcmid: 05 error were observed. After replacing the lm 34 temperature sensor and pic 16 board, 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 similar complaint reported for thermogard xp ivtm console with serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188220752]
During device check, the thermogard console (sn (b)(4)) displayed tcmid: 05 (coolant diff failure). No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00232 |
| MDR Report Key | 9808770 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2011-11-30 |
| Date Added to Maude | 2020-03-09 |
| 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 | 2020-03-09 |
| 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 | 2020-03-09 |