FDA Adverse Event Malfunction Summary report: N

TELEREHAB VERSACARE SYSTEM

MDR report key: 3835800 · Received May 21, 2014

Report

Report Number
MW5036291
Event Type
Malfunction
Date Received
May 21, 2014
Date of Event
May 16, 2014
Report Date
May 20, 2014
Manufacturer
SCOTTCARE
Product Code
DRG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
301793 TELEREHAB VERSACARE SYSTEM TELEREHAB VERSACARE SYSTEM DRG SCOTTCARE TELEREHAB VERSACARE

Patients

Seq Age Sex Outcome Treatment
1 Other