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

Catalog Number UNK_MED

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 05/11/2018

Event Type  Injury  

Event Description

It was reported that the patient was cooled with the altrix and received a thermal burn while being cooled.Further information was not provided.

Manufacturer Narrative

It was alleged that a patient experienced a "burn" while using a cooling blanket with the altrix machine.It was identified that the skin issue was identified to be located on the upper left back of the patient and had an appearance of a "scrape" along the back.It was reported that the account uses cooling blankets but did not have the exact model number or lot number of the blankets used in this circumstance.It was reported that altrix machines are used for fever management of patients and the patient in this event would have experienced cooling therapy for fever management, however, it could not be confirmed the exact settings used.The serial number of the altrix unit that had been used was not recorded at the time of the event.It was reported that patients should be monitored every 2 hours per hospital protocol, however this could not be confirmed for this patient.There was no defect or malfunction of the product alleged.The user facility did not know exact details of medical intervention for the patient but stated that "garden variety" wound treatment was used.Based on the injury detail, the injury was likely an abrasion to the skin from the blanket due to mechanical forces such as friction or shear.Feedback on recommended use of the blankets and importance of monitoring patient skin condition was provided to the user facility.Actual device could not be identified.

Event Description

It was reported that the patient was cooled with the altrix and received a thermal burn while being cooled.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: 7572648
• MDR Text Key: 110169809
• Report Number: 0001831750-2018-00522
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2018
• 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