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

Catalog Number 8001061610

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Event 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 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.

Manufacturer Narrative

The device could not be evaluated.The customer discarded the blanket and did not document the lot number.H3 other text : device was discarded.

• Brand Name: BLKT 1-SIDE NONWOV COLDER CON
• 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: 18616698
• MDR Text Key: 334385381
• Report Number: 0001831750-2024-00299
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 57613327175122
• UDI-Public: 57613327175122
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1