MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. VASO FORCE; INTERMITTENT AND SEQUENTIAL DVT PUMP

Model Number MDS600

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/24/2017

Event Type  malfunction  

Event Description

The spring loaded hooks on the compression units continue to break with placed on the end of beds.This is a continuous problem.

• Brand Name: VASO FORCE
• Type of Device: INTERMITTENT AND SEQUENTIAL DVT PUMP
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 7009456
• MDR Text Key: 91343686
• Report Number: 7009456
• 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
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: MDS600
• Device Catalogue Number: MDS600
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1