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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
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2014
Event Type  malfunction  
Event Description
It was reported that the device was running at a higher temperature set point than it was set at due to a damaged pc board and sensor assembly.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported that the device was running at a higher temperature set point than it was set at due to a damaged pc board and sensor assembly.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The product was not received; therefore, the event could not be confirmed.The customer was issued a new component assembly.Device not returned.
 
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Brand Name
CAPITAL TEMP PUMP PROFESSIONAL
Type of Device
PACK, HOT OR COLD, WATER CIRCULATING
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 Key4334757
MDR Text Key5252705
Report Number0001831750-2014-03412
Device Sequence Number1
Product Code ILO
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
Type of Report Initial,Followup
Report Date 12/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberTP700
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/12/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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