MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for MEDI-THERM III ECD01-A manufactured by Gaymar Industries, Inc..
[144865170]
Patient undergoing targeted temperature management using gaymar machine and wraps. During maintenance portion of protocol, machine noted to be heating water temperature and elevating patient's core temp beyond desired number. Rn evaluated equipment and lines with co-workers. No visible issues to be adjusted with equipment, unknown cause of malfunction. Ice packs applied and patient care equipment notified that we need a new gaymar machine. Nursing forced to utilize cooling blanket and ice packs to keep patient at goal temp while continuing to attempt troubleshooting on only gaymar device available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8603274 |
| MDR Report Key | 8603274 |
| Date Received | 2019-05-13 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-20 |
| Report Date | 2019-04-25 |
| Date Reported to FDA | 2019-04-25 |
| Date Reported to Mfgr | 2019-05-13 |
| Date Added to Maude | 2019-05-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDI-THERM III |
| Generic Name | SYSTEM, THERMAL REGULATING |
| Product Code | PLA |
| Date Received | 2019-05-13 |
| Model Number | ECD01-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAYMAR INDUSTRIES, INC. |
| Manufacturer Address | 3440 S. DEARBORN ST. #215-S CHICAGO IL 60616 US 60616 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-13 |