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

Catalog Number MA 3320-PM

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

When attached to heat source, stryker mistral air heated blanket filled with so much air that the seams popped gradually and turned into a giant inflated balloon.The blanket had to be replaced.The rep for the blanket happened to be here during one of these episodes.He stated he would pass on the concern to his company.After discussing this with our team, it has been reported at least 12 times.Lot 2020101, ref ma 3320-pm.

• Brand Name: MISTRAL AIR
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): THE SURGICAL COMPANY INTERNATIONAL B.V.; 3800 e. centre; portage MI 49002
• MDR Report Key: 11494678
• MDR Text Key: 240099985
• Report Number: 11494678
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MA 3320-PM
• Device Lot Number: 2020101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1