MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for RAPR-ROUND 8001-061-530 manufactured by Stryker Corporation.
[118412153]
Patient is admitted status post cardiac arrest. Md ordered hypothermia protocol to be applied. Obtained cooling wraps/blanket with a goal temp of 36. Cooling blanket states it is cooling patient with a water temperature of 27. Cooling blanket feels as though it is room temperature, and the patient's temp continued to rise.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7822183 |
| MDR Report Key | 7822183 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-11 |
| Report Date | 2018-08-15 |
| Date Reported to FDA | 2018-08-15 |
| Date Reported to Mfgr | 2018-08-28 |
| Date Added to Maude | 2018-08-28 |
| 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 | RAPR-ROUND |
| Generic Name | SYSTEM, THERMAL REGULATING |
| Product Code | PLA |
| Date Received | 2018-08-28 |
| Model Number | 8001-061-530 |
| Catalog Number | 8001-061-530 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORATION |
| Manufacturer Address | 3440 S DEARBORN ST STE 215-S CHICAGO IL 60616 US 60616 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-28 |