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

Model Number TP700

Device Problem Excessive Heating (4030)

Patient Problems Burn(s) (1757); Skin Irritation (2076)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the fda voluntary malfunction summary reporting program.The device was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported there was excessive heating.The patient sustained a burn/skin irritation.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 10320404
• MDR Text Key: 200241114
• Report Number: 0001831750-2020-00796
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TP700
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1