MAUDE Adverse Event Report: MEDLINE VASO-FORCE; SLEEVE, LIMB, COMPRESSIBLE

Model Number VASO-FORCE

Device Problems Break (1069); Crack (1135)

Patient Problem No Information (3190)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

The plastic front panel of these scd (sequential compression device) devices frequently crack and break out at the button locations.The switch actuator behind the panel is left exposed, but still functions.Manufacturer response for sequential compression device, (brand not provided) (per site reporter).
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membrane control panels are available for purchase as repair parts.

• Brand Name: VASO-FORCE
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): MEDLINE; 1 medline place; mundelein, IL 60060
• MDR Report Key: 4198704
• MDR Text Key: 19970873
• Report Number: 4198704
• Device Sequence Number: 1
• Product Code: JOW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: VASO-FORCE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1