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

Catalog Number	8001061610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer hooked the patient up to the cooling blanket and the blanket was noticed to have holes.The holes were noticed immediately after hooking up to the machine, because water started spraying out of holes in the middle of the blanket.No adverse consequence or clinically relevant delay in treatment was reported.
Event or Problem Description
It was reported that the customer hooked the patient up to the cooling blanket and the blanket was noticed to have holes.The holes were noticed immediately after hooking up to the machine, because water started spraying out of holes in the middle of the blanket.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
The device could not be evaluated.The customer discarded the blanket and did not document the lot number.

• 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: 18616693
• Report Number: 0001831750-2024-00298
• Device Sequence Number: 11364374
• Product Code: DWJ
• UDI-Device Identifier: 57613327175122
• UDI-Public: 57613327175122
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K152266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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 Catalogue Number: 8001061610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown