MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-12-22 for LIFELINE PERSONAL RESPONSE SYSTEM FD100 manufactured by Lifeline, Inc..
[95600348]
As reported to fda per 1220762-11-15-2017-001-r, the involved button is part of a field action on the part of the manufacturer. The involved button did not have the appropriate fall parameters. It is unclear from the information provided to the manufacturer if the button may have contributed to any injury the subscriber sustained. The involved button was still able to be depressed to summon help. Per autoalert help button, instructions for use (p/n 0940718 rev. 7) p. 10 the autoalert help button can detect most falls, providing an added layer of protection. If you think you need assistance, push your help button immediately to initiate the help call. Pushing the help button generates the help call immediately. P. 13 recommended usage push your autoalert help button any time you need help. If you fall and are able to, you should still push the autoalert button to send a help call right away. Per autoalert help button, instructions for use, p/n 0940718 rev. 7 p. 5 states: "in certain situations, the autoalert help button may not detect a fall. 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; lowering oneself slowly to the ground (to brace the impact of a fall) , a fall from a height of less than 20 inches (0. 5 meters). "
Patient Sequence No: 1, Text Type: N, H10
[95600349]
The subscriber was unable to provide a date of the fall. She stated she had fallen forward and was unable to move. She stated she was on the floor for 6 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220762-2017-00002 |
| MDR Report Key | 7141825 |
| Report Source | CONSUMER |
| Date Received | 2017-12-22 |
| Date of Report | 2017-12-20 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2017-09-21 |
| Date Added to Maude | 2017-12-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. INGRID SAWVELLE |
| Manufacturer Street | 111 LAWRENCE ST. |
| Manufacturer City | FRAMINGHAM MA 01702 |
| Manufacturer Country | US |
| Manufacturer Postal | 01702 |
| Manufacturer Phone | 5089881000 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFELINE PERSONAL RESPONSE SYSTEM |
| Generic Name | SYSTEM, COMMUNICATOR, POWERED |
| Product Code | ILQ |
| Date Received | 2017-12-22 |
| Returned To Mfg | 2017-12-06 |
| Model 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, INC. |
| Manufacturer Address | 111 LAWRENCE ST. FRAMINGHAM MA 01702 US 01702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-12-22 |