MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BLKT 1-SIDE NONWOV COLDER CON; THERMAL REGULATING SYSTEM

Model Number	8001-061-610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Alteration in Body Temperature (4568)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the altrix blanket began to leak onto the patient while in use, causing the patient's temperature to drop to 35c.The user facility reported that there was a 3-5 minute delay in treatment as they replaced the grounding pad but confirmed the procedure was successfully completed.
Additional Manufacturer Narrative
Investigation is complete; h codes updated to reflect investigation results.
Event or Problem Description
It was reported that the altrix blanket began to leak onto the patient while in use, causing the patient's temperature to drop to 35c.The user facility reported that there was a 3-5 minute delay in treatment as they replaced the grounding pad but confirmed the procedure was successfully completed.

• Brand Name: BLKT 1-SIDE NONWOV COLDER CON
• Common Device Name: THERMAL REGULATING SYSTEM
• 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: kaitlyn matheny ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12469473
• Report Number: 0001831750-2021-01324
• Device Sequence Number: 19767071
• Product Code: DWJ
• UDI-Device Identifier: 07613327175127
• UDI-Public: 07613327175127
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8001-061-610
• Device Catalogue Number: 8001061610
• Device Lot Number: 0841A4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown