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 |