MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-04-13 for LIFELINE PERSONAL RESPONSE SYSTEM FD100 manufactured by Philips Lifeline.
[105452162]
As reported to fda in 1220762-11-15-2017-001-r, the involved button was an affected device. The button did not have the appropriate fall parameters. It is unclear from the information received by the manufacturer if the button may have contributed to any injury the subscriber sustained. Per autoalert help button, instructions for use (p/n 0940817 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. 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 help button to send a help call right away. Per autoalert help button, instructions for use, p/n 0940718 rev. 5 page states: "in certain situations, the autoalert may not detect a fall. Some movements may not register as a fall and would not be detected. " the involved button was still able to be depressed to summon help.
Patient Sequence No: 1, Text Type: N, H10
[105452163]
The subscriber had a fall down several stairs. She was unconscious. She was bleeding from the fall and had broken several bones.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220762-2018-00001 |
| MDR Report Key | 7429876 |
| Report Source | CONSUMER |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-19 |
| Device Manufacturer Date | 2017-09-25 |
| Date Added to Maude | 2018-04-13 |
| 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 017028156 |
| Manufacturer Country | US |
| Manufacturer Postal | 017028156 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFELINE PERSONAL RESPONSE SYSTEM |
| Generic Name | SYSTEM, COMMUNICATION, POWERED |
| Product Code | ILQ |
| Date Received | 2018-04-13 |
| Returned To Mfg | 2018-03-28 |
| Model Number | FD100 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS LIFELINE |
| Manufacturer Address | 111 LAWRENCE ST FRAMINGHAM MA 017028156 US 017028156 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-13 |