MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-04-15 for MOBILEHELP CLASSIC IGB-01 manufactured by Integrity Tracking Dba Mobilehelp.
[3641678]
Earl called stating that today his wife fell, pressed button, nothing happened.
Patient Sequence No: 1, Text Type: D, B5
[10916273]
The device did not cause or contribute to the reported injury. The injury occurred as a result of a fall, reported by the subscribers husband. The device is intended to be used to summon help in an emergency. Device was retruded an evaluated, and it was determined that a component failure affected the way the device communicates to the central station. Device is not labeled as a life sustaining device. The intended use indicates that receipt of the alarm is not guaranteed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008101184-2013-00002 |
| MDR Report Key | 3266650 |
| Report Source | 04 |
| Date Received | 2013-04-15 |
| Date of Report | 2013-04-10 |
| Date of Event | 2013-03-14 |
| Date Mfgr Received | 2013-03-15 |
| Date Added to Maude | 2013-08-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR GARY BECKER |
| Manufacturer Street | 3701 FAU BLVD STE 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 CLASSIC |
| Generic Name | PERSONAL EMERGENCY RESPONSE SYSTEM |
| Product Code | ILQ |
| Date Received | 2013-04-15 |
| Returned To Mfg | 2013-03-27 |
| Model Number | IGB-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRITY TRACKING DBA MOBILEHELP |
| Manufacturer Address | 3701 FAU BLVD STE 300 BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-04-15 |