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

Catalog Number	8001061610
Medical Device Problem Codes	Fluid/Blood Leak (1250); Excessive Cooling (2932); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Discoloration (2074)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blankets positioned under the patient showed significant water imbibition with frost.It was reported that there is seepage at the level of the blanket tubes.It was reported that the patient received significant burns of varying degrees.
Additional Manufacturer Narrative
As a result of this report for a skin injury to the patient, a review of information including photos identified that the water temperature was set at 33 c during therapy.Furthermore, the altrix unit was confirmed to be functioning correctly.Based on the photos and discussion between a stryker engineering manager, customer quality engineer, and a senior staff medical science liaison, it was determined that the patient injury was likely a result of excessive compression force from the blanket.For the issue of fluid leaking onto the patient support surface, it was determined that this was likely due to a broken/damaged blanket assembly.However, this could not be confirmed as the product was discarded prior to being evaluated by a stryker representative.
Event or Problem Description
It was reported that the altrix blanket was leaking and that the patient suffered a skin injury.

• Brand Name: BLKT 1-SIDE NONWOV COLDER CON
• Common Device Name: 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: 19811814
• Report Number: 0001831750-2024-00735
• Device Sequence Number: 8349126
• Product Code: DWJ
• UDI-Device Identifier: 57613327175122
• UDI-Public: (01)57613327175122(10)3250A4
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 8001061610
• Device Lot Number: 3250A4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG