MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-11-12 for MOBILEHELP CELLUAR BASE STATION (CLASSIC) IGBW-01 manufactured by Integrity Tracking Dba Mobilehelp.
[3853393]
Spoke with rich summers/son, his mother tried using system on 10/27/13 @ approx. 5pm pacific time and neck pendant would not work. His mom has a bruised knee, she was found on the floor when they were bringing her dinner.
Patient Sequence No: 1, Text Type: D, B5
[11416703]
A software defect was found in this version of software on this device (r025), which causes the system to hang (rendering any future activations to not work, if the device is activated and no call back is made to the device. Two work arounds have been put in place that mitigates this issue. The monitoring center operator instructs the user to press the reset button after they hang up from the call, and the operator is instructed to answer every alarm from the device, regardless of the time between alarms (duplicate alarms). In addition a report is run by mobile help to look for situations where possible duplicate alarms have occurred, and if, found the unit is called back, which unfreezes the device. Devices with this version (r025) have been isolated to one reseller, and they have been instructed to upgrade to (r026) when the unit is returned, which fixes this issue. This issue is managed via capa (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008101184-2013-00006 |
| MDR Report Key | 3462717 |
| Report Source | * |
| Date Received | 2013-11-12 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-10-27 |
| Date Added to Maude | 2014-02-14 |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILEHELP CELLUAR BASE STATION (CLASSIC) |
| Generic Name | PERSONAL EMERGENCY RESPONSE SYSTEM |
| Product Code | ILQ |
| Date Received | 2013-11-12 |
| Returned To Mfg | 2013-11-07 |
| Model Number | IGBW-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRITY TRACKING DBA MOBILEHELP |
| Manufacturer Address | 3701 FAU BLVD SUITE 300 BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-12 |