MAUDE Adverse Event Report: TSCI BV DBA THE 37COMPANY PREMIUM ADULT - SYK; SYSTEM, THERMAL REGULATING

Catalog Number MA3320-PM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 04/05/2017

Event Type  Injury  

Event Description

It was alleged that a patient was undergoing cardioversion therapy while using the air blanket and received burns.The patient allegedly received 1st and possibly 2nd degree burns around both electrodes that were being used during the cardioversion therapy.One electrode was placed on the sternum and one electrode was placed on the spine.It was reported that there was no medical intervention needed and no lasting adverse effects for the patient.

Manufacturer Narrative

It was reported that the patient was burned during this therapy due to the blanket conducting electricity from the defibrillator.To address this issue a label will be added to the point of use (individual blanket packaging) and the ifu to indicate the correct orientation of the blanket on the patient and a warning to not cover the patient's torso during defibrillation.

Event Description

It was alleged that a patient was undergoing cardioversion therapy while using the air blanket and received burns.The patient allegedly received 1st and possibly 2nd degree burns around both electrodes that were being used during the cardioversion therapy.One electrode was placed on the sternum and one electrode was placed on the spine.It was reported that there was no medical intervention needed and no lasting adverse effects for the patient.

• Brand Name: PREMIUM ADULT - 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6541856
• MDR Text Key: 74360527
• Report Number: 3003312341-2017-00002
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: MA3320-PM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1