MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-03-25 for MOBILEHELP - DUO SYSTEM IGB-01 manufactured by Integrity Tracking, Llc/ Dba Mobilehelp.
[4332968]
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.
Patient Sequence No: 1, Text Type: D, B5
[11617088]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008101184-2014-00008 |
| MDR Report Key | 3697942 |
| Report Source | 04 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-03-17 |
| Date of Event | 2014-02-19 |
| Date Mfgr Received | 2014-02-19 |
| Date Added to Maude | 2014-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. GARY BECKER |
| Manufacturer Street | 3701 FAU BLVD SUITE 300 |
| Manufacturer City | BOCA RATON 33431 |
| Manufacturer Country | US |
| Manufacturer Postal | 33431 |
| Manufacturer Phone | 5613476255 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILEHELP - DUO SYSTEM |
| Generic Name | PERSONAL EMERGENCY RESPONSE SYSTEM |
| Product Code | ILQ |
| Date Received | 2014-03-25 |
| Returned To Mfg | 2014-03-10 |
| Model Number | IGB-01 |
| ID Number | V4.32-R9 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRITY TRACKING, LLC/ DBA MOBILEHELP |
| Manufacturer Address | 3701 FAU BLVD SUITE 300 BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-25 |