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 2020-03-12 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[188221837]
The thermogard xp ivtm console (sn: (b)(4)) was evaluated at the customer site. The reported compliant of "the thermogard system failed to recognize the t1 patient temperature input" was confirmed during functional testing of the thermogard console. The root cause was due to a bent pin in the lower connector printed circuit board (i/o board) which most likely resulted in loose connection between the t1/t2 module cable and the i/o board. The reported complaints of "the pump raceway was contaminated, and the pump rotor was observed corroded" were confirmed during functional testing of the thermogard console. The root cause was due to possible saline spillage, most likely as a result of user mishandling. Visual inspection of the console was performed, and no apparent physical damage was observed. The event log was reviewed, and no error messages were noted. During the functional testing of the console, the temperature probe could not be recognized; thus, confirming the reported complaint. During further investigation, t1/t2 module was tested, and the module functioned as intended. However, there was a bent pin in the i/o board which caused loose connection between the t1/t2 module cable and the i/o board. The pin was straightened to resolve the issue. In addition, further functional testing revealed traces of dried saline on the top and the bottom of the tgxp pump rotor assembly. The raceway was corroded, and the rotor silver rollers were slightly rusted; thus, confirming the reported complaint. Moreover, the roller pump lid was observed broken. The raceway lid assembly with magnet was replaced to address the issues. Following service, the system passed all testing criteria and was put back in clinical use. Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse with serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188221838]
The thermogard xp ivtm system (sn: (b)(4)) failed to recognize the t1 patient temperature input. In addition, the pump raceway was contaminated, and the pump rotor was observed corroded. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00256 |
| MDR Report Key | 9824396 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2017-10-23 |
| 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 |
| 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 | 2020-03-12 |