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 2020-03-17 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[188240706]
The customer's reported complaint of the thermogard console displayed tcmid:06 (ce post failure) was confirmed during the archive review but not during functional testing. Additionally, the console failed with tcmid:02 (cooling engine danfoss error) error during the initial functional testing, as a characteristic of the failed cooling engine as a result of wear and tear. The defective cooling engine was replaced to remedy the customer reported complaint. Upon visual inspection, the cooling engine compressor motor was noted leaking, thus confirming a failed cooling engine. As part of routine service during testing, the console was examined and the well gaskets were noted discolored and white rollers were worn out, the casters and screws on top lid hinge were loose and cover deck xp and front cover were cracked, unrelated to the reported complaint. The thermogard console is a reusable device and was manufactured in september 2011 and is more than 9 years old. The console has exceeded its expected service life of 5 years. Therefore, this type of physical damages found during the visual inspection are characteristics of normal wear and tear for the life of the device. A review of the archive data shows multiple tcmid:06 error messages, thus confirming the customer reported complaint. Following the repair, the thermogard console passed all the testing with no issue or faults observed. All tests and readings are within the specified limits and functioned as intended. Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for the thermogard console with serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188240707]
During a routine check, the thermogard console displayed tcmid:06 (ce post failure) error message. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00272 |
| MDR Report Key | 9845274 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2011-09-02 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Returned To Mfg | 2020-03-10 |
| 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 | 2020-03-17 |