MAUDE Adverse Event Report: TSCI BV DBA THE 37COMPANY MISTRAL-AIR BLOWER, SYK; SYSTEM, THERMAL REGULATING

Catalog Number MA1200-PM

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  malfunction  

Event Description

It was reported that the device produced a small flame (fire).No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the device produced a small flame (fire).No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The investigation is complete, h codes updated to reflect results.

• Brand Name: MISTRAL-AIR BLOWER, SYK
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• MDR Report Key: 12275268
• MDR Text Key: 264995305
• Report Number: 3003312341-2021-00008
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K101705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MA1200-PM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1