MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-20 for LIFELINE PERSONAL RESPONSE SYSTEM FD100 (AAHB) FD100 manufactured by Lifeline Systems, Inc..
[122134328]
The device (aahb and communicator) was returned to the manufacturer on 8/29/2018. The aahb must be programmed to the communicator in order to signal the communicator and have it dial the call center. Upon examination it was discovered the aahb was not programmed to the communicator; therefore, no signals from the returned aahb would be able to signal the response center. Please note that, per the autoalert help button instructions for use, part number 0940718 rev. 7 p. 10, "some movements may not register as a fall and would not be detected. Examples include, but are not limited to: -a gradual slide such as from a seated position -a fall from a height of less than 20 inches (0. 5 meters)" p. 13- if you fall and are able to, you should still push the autoalert help button to send a help call right away. "
Patient Sequence No: 1, Text Type: N, H10
[122134329]
It was reported that the subscriber fell out of bed. She hit her head. The family reported the subscriber passed away as a result of her fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220762-2018-00003 |
| MDR Report Key | 7911594 |
| Report Source | CONSUMER |
| Date Received | 2018-09-20 |
| Date of Report | 2018-09-21 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2018-11-16 |
| Date Added to Maude | 2018-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. INGRID SAWVELLE |
| Manufacturer Street | 111 LAWRENCE ST. |
| Manufacturer City | FRAMINGHAM MA 01701 |
| Manufacturer Country | US |
| Manufacturer Postal | 01701 |
| Manufacturer Phone | 5089881079 |
| Manufacturer G1 | RESPIRONICS, INC. |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15068 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15068 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFELINE PERSONAL RESPONSE SYSTEM |
| Generic Name | SYSTEM, COMMUNICATION, POWERED (ILQ) |
| Product Code | ILQ |
| Date Received | 2018-09-20 |
| Returned To Mfg | 2018-08-29 |
| Model Number | FD100 (AAHB) |
| Catalog Number | FD100 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFELINE SYSTEMS, INC. |
| Manufacturer Address | 111 LAWRENCE ST. FRAMINGHAM MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-09-20 |