MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. VASOFORCE; SLEEVE, LIMB, COMPRESSIBLE

Lot Number 11102103

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

When sequential compression unit hangs over the end of the bed; the weight of the unit is not supported by the design/material used in the hanger and snaps off on a consistent basis.

• Brand Name: VASOFORCE
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5013301
• MDR Text Key: 23408966
• Report Number: 5013301
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Report Date: 07/21/2015,07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 11102103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2015
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1