MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-05-03 for MOBILEHELP - CLASSIC IGB-01 IGB8MK2326 manufactured by Integrity Tracking Llc Dba Mobilehelp.
[16803098]
Call rec'd by mobilehelp support on (b)(6) 2013 at 12:10 pm from (b)(6) regarding (b)(6). He described that on tuesday (b)(6) 2013 at 8:00pm she fell, pressed the button, and laid on the floor 19 hrs. The base station is located in the kitchen. Support called (b)(6) and instructed him to press the pendant button that he said she had been wearing at the time of the incident. Instructed him to press the button until he saw the pendant light flashing; however he had to attempt it multiple times. He reported he did see the light flash, however no alarm was activated from the base station. Instructed him to press the base station emergency button directly which immediately responded with beeping and a 01 alarm was sent to the operator. The operator was able to establish connection and speak with him through the speaker. Instructed him to press the pendant again and he did see the light flash by the pendant button, however the base station did not respond. At that time he (b)(6) requested instructions on how to cancel the service and those instructions were given.
Patient Sequence No: 1, Text Type: D, B5
[17046743]
The device did not cause or contribute to the reported injury. The subscribers brother reported that his sister was on the floor for several hrs before help arrived. Device is intended to summon help as needed. Device was returned and evaluated, and it was determined that the accessory pendant used to activate the device did not work. The device itself was tested and worked as designed. Device is not labeled as a life sustaining device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008101184-2013-00003 |
| MDR Report Key | 3478966 |
| Report Source | 04 |
| Date Received | 2013-05-03 |
| Date of Report | 2013-04-30 |
| Date of Event | 2013-04-15 |
| Date Mfgr Received | 2013-04-11 |
| 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 33431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33431 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILEHELP - CLASSIC |
| Generic Name | PERSONAL EMERGENCY RESPONSE SYSTEM - CLASSIC, PRODUCT CODE: ILQ |
| Product Code | ILQ |
| Date Received | 2013-05-03 |
| Returned To Mfg | 2013-04-12 |
| Model Number | IGB-01 |
| Catalog Number | IGB8MK2326 |
| 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 | 2013-05-03 |