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 2020-03-11 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[188219820]
The thermogard xp ivtm system in complaint will not be returned for investigation. Therefore, a physical investigation will not be performed. A supplemental report will be filed if the product is returned and investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[188219821]
The thermogard console (sn: (b)(4)) did not recognize the air trap. Drying the air trap did not resolve the issue. Also, the user observed traces of coolant (propylene glycol) on the drip pan. After an unknown period of time on the same day, the user dried the air trap, and this time, the air trap was detected. The system was back for clinical use. No further information was provided. No known consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00268 |
| MDR Report Key | 9820934 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Model Number | 8700-0650 |
| Catalog Number | 8700-0650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-11 |