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

Model Number 8001-061-610

Device Problem Fluid/Blood Leak (1250)

Patient Problem Alteration in Body Temperature (4568)

Event Date 09/03/2021

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Investigation is complete; h codes updated to reflect investigation results.

Event 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
• Type of Device: 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
• MDR Text Key: 271332628
• Report Number: 0001831750-2021-01324
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07613327175127
• UDI-Public: 07613327175127
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• 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
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1