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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
Catalog Number TP700
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/22/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the device is failing electrical safety test.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Additional Manufacturer Narrative
It was reported to a stryker technical support specialist during a troubleshooting call that allegedly the unit was failing an electrical safety test.During the call, it was identified this issue was likely due to the power cord however was not confirmed.Device not returned.
 
Event or Problem Description
It was reported that the device is failing electrical safety test.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 Key8531008
Report Number0001831750-2019-00299
Device Sequence Number13543277
Product Code ILO
UDI-Device Identifier07613327169249
UDI-Public07613327169249
Combination Product (Y/N)N
Initial Reporter StateCA
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) 05/03/2019
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 Catalogue NumberTP700
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 03/22/2019
Supplement Date Received by Manufacturer03/22/2019
Initial Report FDA Received Date04/19/2019
Supplement Report FDA Received Date05/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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