MAUDE Adverse Event Report: THE SURGICAL COMPANY INTERNATIONAL B.V. MISTRAL-AIR; SYSTEM, THERMAL REGULATING

Model Number MA2260-PM

Device Problem Microbial Contamination of Device (2303)

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

Event Date 12/20/2018

Event Type  malfunction  

Event Description

Pt was in anesthesia and a sterile forced air warming device was ordered.Crna called to report that upon trying to open and place a mistral-air upper body plus warming blanket on her total joint patient, something sticking to the blanket inside the package.Upon examination, it was a bug that was stuck between the blanket and the unopened package.This did not get opened and did not touch the patient.

• Brand Name: MISTRAL-AIR
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): THE SURGICAL COMPANY INTERNATIONAL B.V.; stryker medical; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 8335562
• MDR Text Key: 136070978
• Report Number: 8335562
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MA2260-PM
• Device Catalogue Number: MA2260-PM
• Device Lot Number: 1834202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1