MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ALTRIX, DOMESTIC; SYSTEM, THERMAL REGULATING

Catalog Number 8001000001

Device Problems Excessive Cooling (2932); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Skin Inflammation/ Irritation (4545)

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that the patient was starting to have bruising to the abdomen during therapy, this progressed into boils, which then included the thighs 48 hrs post therapy.It was also reported that the patients skin was very taut, particularly to the abdomen.

Manufacturer Narrative

The icu director clarified that the injury sustained was a skin reaction.Based on the information from the icu director, the alleged boils, which wouldn't have developed from temperature therapy, were more likely hives.A field service technician spoke with the icu director, who shared that this might have been an error on behalf of the user not setting it correctly.Based on this information, it was determined that the alleged event was not likely due to any component level malfunction with the product.The catalog number and serial number have been added to section d4.The manufacturing date has been added to section h4.

Event Description

It was reported that the patient sustained a skin reaction during cooling therapy.

• Brand Name: ALTRIX, DOMESTIC
• Type of Device: SYSTEM, THERMAL REGULATING
• 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: 18654525
• MDR Text Key: 334699778
• Report Number: 0001831750-2024-00304
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152266
• 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: 05/20/2024

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 Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2023
• 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
• Patient Outcome(s): Other