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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL TEMP PUMP PROFESSIONAL; PACK, HOT OR COLD, WATER CIRCULATING
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STRYKER MEDICAL-KALAMAZOO CAPITAL TEMP PUMP PROFESSIONAL; PACK, HOT OR COLD, WATER CIRCULATING Back to Search Results
Model Number TP700C
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/26/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the device had no over temperature warning.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Additional Manufacturer Narrative
The product was not available for evaluation and no further information was available.
 
Event or Problem Description
It was reported that the device had no over temperature warning.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
CAPITAL TEMP PUMP PROFESSIONAL
Common Device Name
PACK, HOT OR COLD, WATER CIRCULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key7448342
Report Number0001831750-2018-00214
Device Sequence Number13761379
Product Code ILO
UDI-Device Identifier07613327169263
UDI-Public(01)07613327169263
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberTP700C
Device Catalogue NumberTP700C
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 03/26/2018
Supplement Date Received by Manufacturer03/26/2018
Initial Report FDA Received Date04/20/2018
Supplement Report FDA Received Date05/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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