RAPR-ROUND 8001-061-530

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number7822183
MDR Report Key7822183
Date Received2018-08-28
Date of Report2018-08-15
Date of Event2018-08-11
Report Date2018-08-15
Date Reported to FDA2018-08-15
Date Reported to Mfgr2018-08-28
Date Added to Maude2018-08-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAPR-ROUND
Generic NameSYSTEM, THERMAL REGULATING
Product CodePLA
Date Received2018-08-28
Model Number8001-061-530
Catalog Number8001-061-530
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER CORPORATION
Manufacturer Address3440 S DEARBORN ST STE 215-S CHICAGO IL 60616 US 60616


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-28

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