MAUDE Adverse Event Report: THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY MISTRAL-AIR PLUS (115V) BLOWER; THERMAL REGULATING

Model Number MA1100-PM

Device Problems Fire (1245); Melted (1385); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical case a mistral air unit started to produce smoke and caught fire which was immediately extinguished.The hose was reported to have been tapped to repair a split in the heater hose.The tape was reported to have acted as a combustible material which caused the plastic to melt at the hose and device connection.The unit was removed from service immediately and no injury to the pt occurred.

• Brand Name: MISTRAL-AIR PLUS (115V) BLOWER
• Type of Device: THERMAL REGULATING
• Manufacturer (Section D): THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY; beeldschermweg 6f; amersfoort 3821 AH; NL 3821 AH
• Manufacturer Contact: kees van hassel ; beeldschermweg 6f; amersfoort 3821 -AH ; NL 3821 AH ; 334507240
• MDR Report Key: 4284141
• MDR Text Key: 15116446
• Report Number: 3003312341-2014-00008
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MA1100-PM
• Device Catalogue Number: MA1100-PM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2014
• Distributor Facility Aware Date: 09/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2014
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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