MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO HYPER\HYPOTHERMIA BLANKET; SYSTEM, THERMAL REGULATING

Catalog Number DHP810

Device Problems Leak/Splash (1354); Moisture Damage (1405)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2016

Event Type  malfunction  

Event Description

It was alleged during a procedure that the blanket was under the patient and about 1 hr to 2 hrs in to the procedure there was flooding on the floor, but the patient wasn't alleged to have been wet.It was alleged that the leak was off to the side of the blanket.No adverse consequences or medical intervention was reported.

Manufacturer Narrative

The issue was resolved for the customer by replacing the blanket for the customer.The blanket involved in the alleged event was disposed of by the customer.

Event Description

It was alleged during a procedure that the blanket was under the patient and about 1 hr to 2 hrs in to the procedure there was flooding on the floor, but the patient wasn't alleged to have been wet.It was alleged that the leak was off to the side of the blanket.No adverse consequences or medical intervention was reported.The blanket was not made available for evaluation by stryker, and the issue was resolved for the customer by sending a replacement blanket.

• Brand Name: HYPER\HYPOTHERMIA BLANKET
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5760120
• MDR Text Key: 49239354
• Report Number: 0001831750-2016-00214
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DHP810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• 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