MAUDE Adverse Event Report: COMPRESSION THERAPY CONCEPTS, INC. VASOPRESS; SLEEVE, LIMB, COMPRESSIBLE

Model Number	VP520L
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Air tube is loose and falls out of foot sleeve when patient moves their foot or device is turned on.Several of the foot sleeves have been found with loose tubes causing this issue multiple times.This defect renders the foot sleeve unusable and staff has to open multiple packages to find foot sleeves with secure tubing.

• Brand Name: VASOPRESS
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COMPRESSION THERAPY CONCEPTS, INC.; 555 industrial way w; eatontown NJ 07724
• MDR Report Key: 6951581
• Report Number: 6951581
• Device Sequence Number: 16314432
• Product Code: JOW
• UDI-Device Identifier: 00815245010581
• UDI-Public: (01)00815245010581(10)1702264DD
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2017
• Report Date (Section F): 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: VP520L
• Device Lot Number: 1702264DD
• Other Device ID Number: VP520L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/13/2017