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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 Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 04/27/2015
Event Type  malfunction  
Event Description
It was reported that it was noticed that the patient had burn marks that looked like "honeycomb" marks that allegedly came from the pad of the t pump.The hospital does not have the serial number, details of length of therapy, or t-pump settings.Further information has not been provided.
 
Manufacturer Narrative
It was reported that after a hospital stay, the patients¿ spouse noticed ¿honeycomb¿ marks on the patients¿ skin allegedly due to the pad of the t-pump.The alleged burns were not diagnosed by a medical professional and no treatment was given for the alleged burns.The device was evaluated by the user facility biomed department and no defects were found.After speaking with the user patients¿ and reviewing the product manual, it was also identified that the nursing staff were not performing skin checks every 30 minutes as stated in the product manual.Evaluated by the user facility.
 
Event Description
It was reported that it was noticed that the patient had burn marks that looked like "honeycomb" marks that allegedly came from the pad of the t pump.The hospital does not have the serial number, details of length of therapy, or t-pump settings.
 
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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 Key4901791
MDR Text Key6534831
Report Number0001831750-2015-00332
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,user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
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
Initial Date Manufacturer Received 06/12/2015
Initial Date FDA Received07/09/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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