MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-05-14 for MOBILEHELP - CLASSIC BASE STATION IGB-01 IGB8LY22JM manufactured by Integrity Tracking Llc Dba Mobilehelp.
[4020363]
On (b)(6) 2013 around 10am, subscriber fell just outside of her home. Her head hit a brick and she had a gash and was bleeding badly. She said the situation was life threatening. Her daughter (b)(6) said she lives next door and heard her mom yell, when she went over to her, her mom said she already pressed the neck pendant button so subscriber assumed ems was on the way. Daughter went into the home and heard the base station beeping and called 911 and reset the base station. The mobile device was sitting in the base station charger.
Patient Sequence No: 1, Text Type: D, B5
[11256544]
The device did not cause or contribute to the reported injury. The subscriber fell and pushed the button to get help. The subscribers daughter heard the mother asking for help, and called 911. The base station was beeping, and the subscribers daughter hit reset to silence the alarm. The device is intended to summons for help as needed. Device was returned and evaluated and it was determined that the base station did not connect to the monitoring center. It is unk if the mobile device connected. The device is not labeled as a life sustaining device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008101184-2013-00004 |
| MDR Report Key | 3478968 |
| Report Source | 04 |
| Date Received | 2013-05-14 |
| Date of Report | 2013-04-15 |
| Date of Event | 2013-04-15 |
| Date Mfgr Received | 2013-04-15 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2013-12-26 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| 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 |
| Manufacturer G1 | INTEGRITY TRACKING LLC DBA MOBILEHELP |
| Manufacturer Street | 3701 FAU BLVD SUITE 300 |
| Manufacturer City | BOCA RATON FL 33431000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33431 0000 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILEHELP - CLASSIC BASE STATION |
| Generic Name | PERSONNAL EMERGENCY RESPONSE SYSTEM - CLASSIC, PRODUCT CODE: ILQ |
| Product Code | ILQ |
| Date Received | 2013-05-14 |
| Returned To Mfg | 2013-05-01 |
| Model Number | IGB-01 |
| Catalog Number | IGB8LY22JM |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2013-05-14 |