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

Model Number MA1100-PM

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

The customer reported that power cord is damaged causing the outlet to spark.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• 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
• Manufacturer (Section G): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 10334458
• MDR Text Key: 202362458
• Report Number: 3003312341-2020-00004
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: ET37MA1100PM03
• UDI-Public: +ET37MA1100PM03
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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: 07/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2016
• 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