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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL HYPER HYPOTHERMIA SYSTEM, THERMAL REGULATING

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STRYKER MEDICAL-KALAMAZOO CAPITAL HYPER HYPOTHERMIA SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number MTA6900
Device Problem Display or Visual Feedback Problem (1184)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 09/23/2019
Event Type  malfunction  
Event Description
It was reported via medwatch mw5090211 that the patient was on a heating blanket per heating/cooling machine. The probe was reading 93. 3 and another rectal probe was utilized to check temperature which read 106. 5. It was reported that the patient was seriously injured requiring intervention. Further information was not provided.
 
Manufacturer Narrative
It was reported that there was no injury to the patient. A serial number for the unit has been added. The type of pad used was not recorded. The unit was examined by an internal biomed service and no defect was found.
 
Event Description
It was reported via medwatch mw5090211 that the patient was on a heating blanket per heating/cooling machine. The probe was reading 93. 3 and another rectal probe was utilized to check temperature which read 106. 5.
 
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Brand NameCAPITAL HYPER HYPOTHERMIA
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key9343545
MDR Text Key167041535
Report Number0001831750-2019-01211
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMTA6900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/25/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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