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.
[188226325]
The thermogard xp ivtm console (sn: (b)(4)) was evaluated at the customer site. The reported complaint of "the display head's rotary encoder of the thermogard xp ivtm system (sn: (b)(4) was hard to press" was not confirmed during functional testing. There was no device malfunction on the ivtm thermogard system, and the rotary encoder functioned as intended. During visual inspection, there was no physical damage observed on the ivtm thermogard console. The event log review showed no significant discrepancies. The ivtm thermogard console passed the initial functional testing with no issues; therefore, the reported complaint was not confirmed. The rotary encoder was deburred and dusted as a precautionary measure. Following service, the ivtm system passed all testing criteria.
Patient Sequence No: 1, Text Type: N, H10
[188226326]
The display head's rotary encoder of the thermogard xp ivtm system (sn: (b)(4)) was hard to press. According to the customer, while turning the rotary encoder at some angles, the "enter function" did not seem to work as intended. Nevertheless, the display head was still readable. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00320 |
| MDR Report Key | 9826798 |
| 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 | 2019-09-04 |
| 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 |