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 03/25/2021

Event Type  malfunction  

Event Description

It was reported that the device did not pass the electrical safety test.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was identified that the device did not pass the electrical safety test due to a broken/damaged power cord.

Event Description

It was reported that the device did not pass the electrical safety test.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
• MDR Report Key: 11666193
• MDR Text Key: 259391558
• Report Number: 3003312341-2021-00002
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1