MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-16 for MOBILEHELP - DUO SYSTEM IGB-01 manufactured by Integrity Tracking Llc / Dba Mobilehelp.
[19687624]
Spoke with (b)(6), she called to cancel service because on sunday (b)(6) 2013 she fell on floor, press button several times on neck pendant, saw the red light on neck pendant but base station (bs) nor mobile device did not signal for help. -- on (b)(6) 2013, there was no alert from her unit, the last time we received an alert was on (b)(6) 2012 and it was an eb (emergency button). -(b)(6) said she's had enough and wanted to cancel service and have her money refunded. Asked her to give us another chance with a new unit, she did not wish to test the system.. On (b)(6) 2013, we received lb from md -she stated she was approx. 10 feet away from bs, she crawled on the floor, used her feet to knock over her home phone to call for assistance. -she stated she was hospitalized for 3 days.
Patient Sequence No: 1, Text Type: D, B5
[19760013]
The base station (bs) lost training to the neck pendant. This can occur if the emergency button is pressed and held down for more than 10 secs, putting the device into training mode, and not completing the training by pushing the pendant button. It is unknown if this was the cause of the lost of training. The mobile device tested ok upon return, to the factory. The event logs showed a low battery (lb) event on (b)(6) 2013, and therefore, it is possible that the mobile device (md) may have been out of power. The user manual indicates the device(s) should be tested on a monthly basis, and it also explains the correct way to charge the mobile device. The failure of the device(s) to alarm did not contribute to the serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008101184-2013-00005 |
| MDR Report Key | 3350925 |
| Report Source | 07 |
| Date Received | 2013-09-16 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-08-04 |
| Date Mfgr Received | 2013-08-23 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2013-12-23 |
| 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 FL 33431 |
| Manufacturer Country | US |
| Manufacturer Postal | 33431 |
| Manufacturer Phone | 5613476255 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 2013-09-16 |
| Returned To Mfg | 2013-08-23 |
| Model Number | IGB-01 |
| 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. Hospitalization | 2013-09-16 |