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 2020-03-03 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[186584159]
The reported complaint of "the ivtm thermogard system (sn: (b)(4)) displayed tcmid:05 (coolant diff failure) error message" was confirmed based on the event log review but not confirmed during the initial functional testing. The investigation findings revealed a defective lm 34a/b temperature sensor which was likely causing the console to display tcmid:05 intermittently. The root cause for the defective component could be due to normal wear and tear. The thermogard console is a reusable device and was manufactured in august 2012, well beyond its expected serviceable life of 5 years. Visual inspection of the thermogard xp ivtm console was performed, and no issues were observed. The event logs were reviewed and confirmed the occurrence of the tcmid:05 error message around the customer reported event date; thus, confirming the reported complaint. In addition, review of the event logs showed tcmid:07 (coolant temp high) error message to have occurred around the customer reported event date. The root cause for both tcmid:05 and tcmid:07 was due to defective lm34a/b temperature sensor. The defective lm34 temperature sensors was replaced to address the error messages. The thermogard xp ivtm system passed the initial functional testing, unable to duplicate the customer reported complaint. Following service, the thermogard xp ivtm system passed the final testing without any error. Historical complaints were reviewed for service information related to the reported complaint, and there was one similar complaint reported for thermogard with serial number (b)(4). Ccr (b)(4) was reported on 09/28/2016, and the lm34a/b sensor was replaced to remedy the issue.
Patient Sequence No: 1, Text Type: N, H10
[186584160]
Upon completion of patient ivtm treatment, after the rewarming phase, the thermogard xp ivtm system (sn: (b)(4)) displayed tcmid:05 (coolant diff failure) error message. No consequences or impact to patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00206 |
| MDR Report Key | 9781927 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-03 |
| Returned To Mfg | 2020-02-07 |
| 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 | 2020-03-03 |