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

Model Number MA1100-PM

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2014

Event Type  No Answer Provided  

Event Description

It was reported that the mistral air had a burn mark in the blower hose.

Manufacturer Narrative

The unit was replaced.

• Brand Name: MISTRAL AIR PLUS (115V) BLOWER
• Manufacturer (Section D): THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY; beeldschermweg 6f; amersfoort 3821 ; NL 3821
• Manufacturer Contact: kees van hassel ; beeldschermweg 6f; amersfoort 00003-821 ; NL 00003821 ; 334507240
• MDR Report Key: 4360655
• MDR Text Key: 5117254
• Report Number: 3003312341-2014-00016
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K10705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• 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 the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2014
• Event Location: Ambulatory Surgical Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1