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

Catalog Number MA1200-PM

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation not requested by customer.

Event Description

It was reported during a troubleshooting call that the unit had a damaged power cord with exposed bare wires.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• 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
• Manufacturer (Section G): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• Manufacturer Contact: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12508317
• MDR Text Key: 272688681
• Report Number: 3003312341-2021-00009
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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: 09/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2018
• 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