MAUDE Adverse Event Report: SCOTTCARE TELEREHAB VERSACARE SYSTEM

Model Number TELEREHAB VERSACARE

Device Problems Failure to Back-Up (1047); Image Display Error/Artifact (1304); Data Back-Up Problem (2902); Loss of Data (2903); Data Problem (3196); Patient Data Problem (3197)

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

Event Date 05/16/2014

Event Type  malfunction  

Event Description

We purchased on (b)(6) 2012 a telerehab versacare-telemetry system from scottcare cardiovascular solutions (b)(4).This equipment has not functioned as represented at the time of the sale.Our staff has documentation going back to time of purchase, of the many issues they have encountered.Some of the issues we have encountered have been sessions mis-numbers pts randomly, pop-ups (notes) display unviewed and don't always come up, post-session comments do not always save, saved sessions are randomly missing, blood pressure readings that are entered by staff are randomly missing, weights entered change randomly, documentation of pt education does not always save, system is randomly not transferring to next mode, mets is incorrect, system fails to save risk factors, timed comments show up under the wrong pt, saved tele-strips change to unsaved, versacare network will malfunction and cause the display to be interrupted.I sent a letter to the company (b)(6) 2013 outlining the issues and requesting a full refund and the removal of the equipment.After the letter was sent we were contacted and a phone conference was held.We were told at that time that most of the issues we were experiencing wold be addressed in a software revision due out at the end of the first quarter.We verbally agreed that we would work with them to resolve these issues with the software revision but we may request a full refund if this could not bring satisfaction.Scottcare also replaced the computer tower (the second time) and sent a repair tech to install it and to rule out any setup issue.Scottcare originally sent the wrong update disk and had to resend the update with the correct disk.Update was installed but we are continuing to experience problems with the system.

• Brand Name: TELEREHAB VERSACARE SYSTEM
• Type of Device: TELEREHAB VERSACARE SYSTEM
• Manufacturer (Section D): SCOTTCARE; cleveland 44135
• MDR Report Key: 3835800
• MDR Text Key: 4502501
• Report Number: MW5036291
• Device Sequence Number: 1
• Product Code: DRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TELEREHAB VERSACARE
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other