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

Model Number MA1100-PM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Event Description

It was reported that there was a ground fault error.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that there was a ground fault error.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was identified that there were no defects or malfunctions related to the ground fault error of the device.

• Brand Name: MISTRAL-AIR PLUS (115V) BLOWER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• MDR Report Key: 8174315
• MDR Text Key: 131382609
• Report Number: 3003312341-2018-00007
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: ET37MA1100PM03
• UDI-Public: +ET37MA1100PM03
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MA1100-PM
• Device Catalogue Number: MA1100-PM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1