MAUDE Adverse Event Report: INTEGRITY TRACKING, LLC/ DBA MOBILEHELP MOBILEHELP - DUO SYSTEM; PERSONAL EMERGENCY RESPONSE SYSTEM

Model Number IGB-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Code Available (3191)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 around 7:50am subscriber fell and needed help inside her home.Subscriber pressed her pendant multiple times but did not get a response.She also pressed her mobile device that was in her purse and did not get a response.She was on floor for about 1.5 hours until (b)(6) (relative) had someone go check on her because she wasn't answering her phone.Subscriber is in rehab now after having some kind of outpatient surgery performed.Subscriber has a compressed stress fracture.

Manufacturer Narrative

Base station lost training to the pendant.This resulted in the base station failing to activate when the pendant button was pushed.The mobile device showed a low battery signal on (b)(6) 2014, indicating a strong possibility that it lost power, and therefore, the mobile device button press resulted in the unit not activating.The devices were swapped out with the latest version of the base station (cellular) and the mobile device.The system is now functional.

• Brand Name: MOBILEHELP - DUO SYSTEM
• Type of Device: PERSONAL EMERGENCY RESPONSE SYSTEM
• Manufacturer (Section D): INTEGRITY TRACKING, LLC/ DBA MOBILEHELP; 3701 fau blvd; suite 300; boca raton FL 33431
• Manufacturer Contact: gary becker ; 3701 fau blvd; suite 300; boca raton 33431 ; 5613476255
• MDR Report Key: 3697942
• MDR Text Key: 4332968
• Report Number: 3008101184-2014-00008
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IGB-01
• Other Device ID Number: V4.32-R9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2014
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other