MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-09-04 for LIFELINE PERSONAL RESPONSE SYSTEM 6900AT manufactured by Lifeline Systems, Inc..
[119031153]
Per the reporter, it is unclear if the subscriber did try to depress her personal help button (phb) after the reported incident. Service records for the subscriber were reviewed. The subscriber had a traditional phb which needs to be depressed in order to signal the call center. On (b)(6) 2017 the subscriber phoned customer service and stated she had lost her phb. A replacement phb was mailed, and on aug. 30, 2017 the subscriber again phoned into the customer service for help in programming her new phb. The replacement phb was successfully programmed and functional. Each phb had a distinct radiofrequency code that must be programmed to the communicator in order for it to be functional. The subscriber had a 6900at communicator which by design has an automatic test feature. Our review of maintenance signals indicates that the communicator and the replacement phb were fully functional prior to and after the event. On the evening of (b)(6) 2018 the daughter depressed the "help button" of the communicator. When the daughter spoke to the call center agent, she informed her that she had just tried to depress the phb and it did not signal the cal center. The agent assisted the daughter with programming the phb to the communicator and it successfully signalled the call center. Our conclusion after reviewing all available service records, is that the replacement phb, which had been sent to the subscriber, was not the phb being used during the reported incident. It is likely the phb used during the time of the incident was the "lost" phb from august 2017 which was no longer programmed to the communicator.
Patient Sequence No: 1, Text Type: N, H10
[119031154]
As reported by the daughter in medwatch number, mw5078663, "i found my mom on her bedroom floor, barely conscious with her phillips life alert portable around the neck button by her side. Later that evening, i went to her home and pushed her button to get no answer from the life alert staff. I then pushed the main box. Although it is clear, when the neck button was pushed, no signal went to phillips. But, because i was not physically there, i cannot know for sure that she pushed it. All signs show that she may have tried, but i was not there. The button was with her when i found her. The main unit on her night stand did work, which i tried later that night after i realized the neck button did not work. That's when the rep told me the neck button was not activated. Assy: 184059, mfg date: 02/28/2012. Rev 02, fcc id: bdz6200 ic: 655c-6700, ic: 655c-6700, r date: 03/03/2015, l6900at. Barcode (b)4. Neck button was not activated therefore no call was placed to phillips. "
Patient Sequence No: 1, Text Type: D, B5
[129930607]
The communicator arrived back and underwent investigation. There were no personal help button(s) returned with the communicator. The communicator underwent a series of visual examinations and functional tests. The communicator passed all visual exams and functional tests, no fault was found with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220762-2018-00002 |
| MDR Report Key | 7841539 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-09-04 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-08-06 |
| Device Manufacturer Date | 2012-02-28 |
| Date Added to Maude | 2018-09-04 |
| 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 |
| 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 | 2018-09-04 |
| Returned To Mfg | 2018-09-20 |
| Model Number | 6900AT |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFELINE SYSTEMS, INC. |
| Manufacturer Address | 111 LAWERENCE ST. FRAMINGHAM MA 01702 US 01702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Deathisabilit | 2018-09-04 |