MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL TEMP PUMP PROFESSIONAL; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number	TP700
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient allegedly received burn marks from the therapy pad.Further information has not been provided.
Additional Manufacturer Narrative
As the product was alleged to not exceed a temperature of 105°f, the product would not reach a temperature high enough to cause a burn.For a burn to occur, the product would need to be greater than 44°c (111°f).Without a failure of the backup and primary thermostats, the highest temperature the t-pump can reach is 42°c (107°f).It is likely that the resident experienced reactive hyperemia which was interpreted to be a burn, however, this could not be confirmed as the account was not available for further information.Further information was not available.
Event or Problem Description
It was reported that the patient allegedly received burn marks from the therapy pad.Further information has not been provided.

• 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 Key: 8812847
• Report Number: 0001831750-2019-00609
• Device Sequence Number: 3109501
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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): 09/20/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1