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

Model Number	8001-061-610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded.
Event or Problem Description
It was reported that while in use with a patient the blanket started leaking beyond the connection.It was further reported that water was running down the clear tubing from the blanket itself indicating there may be a hole in the blanket.The patient was not adversely affected and no clinically relevant delay in treatment was reported.

• 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
• MDR Report Key: 11728909
• Report Number: 0001831750-2021-00894
• Device Sequence Number: 14439736
• Product Code: DWJ
• UDI-Device Identifier: 07613327175127
• UDI-Public: 07613327175127
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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
• Operator of Device: No Information
• Device Model Number: 8001-061-610
• Device Catalogue Number: 8001061610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1