MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-21 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[184418888]
The device investigation is pending. A follow up report will be filed when the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[184418889]
The thermogard xp ivtm system (sn (b)(4)) displayed tcmid:05 (coolant diff failure) error message. Unknown if the device issue was observed during the patient treatment or device check. No further information was provided. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00166 |
| MDR Report Key | 9742349 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2017-07-10 |
| Date Added to Maude | 2020-02-21 |
| 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 | BIOMEDICAL ENGINEER |
| 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 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 | 2020-02-21 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 8700-0650 |
| Catalog Number | 8700-0650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-21 |