MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-23 for MOBILEHELP BASE STATION - IGB-01 manufactured by Integrity Tracking Llc / Dba Mobilehelp.
[4127085]
Spoke with (b)(6) who reported that his wife, (b)(6) had pressed her black wrist button (bwb) on saturday at 4:45 pm cst (b)(6) 2013 and the led flashed but the base station(bs) did not respond, classic system. Mr. (b)(6) was with his wife at that time when she was having a seizure in the living room so he pressed that black wrist button she was wearing but it flashed and did not activate the alarm, the base station was in the same room. He called 911 directly and she required transport to the hospital.
Patient Sequence No: 1, Text Type: D, B5
[11387855]
The pendant lost its training to the base station igb-01. The pendant was retrained to the unit by the customer support tech. The system was then tested and worked as designed. The subscriber did not want to replace the system. The subscriber was sent the summer newsletter on 6/20/13, which included instructions on pressing the button the correct way to avoid loss of training from occurring. This issue is being managed in capa (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008101184-2013-00007 |
| MDR Report Key | 3533683 |
| Report Source | 04 |
| Date Received | 2013-12-23 |
| Date of Report | 2013-12-23 |
| Date of Event | 2013-11-09 |
| Date Mfgr Received | 2013-11-09 |
| Date Added to Maude | 2014-04-01 |
| 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 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILEHELP BASE STATION - IGB-01 |
| Generic Name | PERSONAL EMERGENCY RESPONSE SYSTEM |
| Product Code | ILQ |
| Date Received | 2013-12-23 |
| Model Number | IGB-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-12-23 |