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.
[188240110]
The reported complaint of the thermogard ivtm system (serial (b)(4)) displaying error message "tcm id:05" (coolant diff failure) was confirmed during initial functional test and event log review. The investigation findings revealed a dirty and corroded sensors of lm-34 probe. The root cause of the reported error was due to an improper maintenance. Unrelated to the reported complaint, a rusted cold well and worn white rollers, missing cold well cap, a weee label, a pan drip and rear bracket screws were observed on the returned thermogard ivtm system during visual inspection. These types of rusted, worn and missing components are likely due to improper maintenance and/or due to normal wear and tear. Cold well, white rollers, cold well cap, a weee label, a pan drip and rear bracket screws were replaced. The thermogard ivtm system was manufactured in march 2011 and it is 9 years old, well past beyond its expected serviceable life of 5 years during archive review, multiple tcm id:05 error messages were observed on the reported event date. Thus, confirming the reported complaint. Initial functional testing on the themogard system failed due to error message "tcm id:05" on the display. To remedy "tcm id:05", the lm34 temperature sensor assembly needs to be replaced. Upon service completion, the thermogard xp ivtm system will be further tested to full specification. Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for thermogard ivtm system with serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188240111]
Customer reported that the thermogard xp ivtm system (serial #(b)(4)) displayed "tcm id:05" (coolant diff failure) error message upon powering on. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00244 |
| MDR Report Key | 9824888 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2011-03-24 |
| 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 | 2020-02-27 |
| 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 |