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

Catalog Number TP700

Device Problem Overheating of Device (1437)

Patient Problem Skin Discoloration (2074)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

It was reported that the pad got hot and the back of the neck was red.Medical intervention was not reported.

Manufacturer Narrative

The user facility stated that the patient complained that the pad was too hot.The patient's neck was checked and the skin was red.It was reported that it was just skin redness and no treatment or medical intervention was needed.It is unknown if the product met specifications as the product was not returned for evaluation.Device not returned.

Event Description

It was reported that the pad got hot and the back of the neck was red.

• 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 Key: 8294869
• MDR Text Key: 134718846
• Report Number: 0001831750-2019-00263
• 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): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2019
• 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 Number: 1