MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for PHILIPS LIFELINE 6900AT manufactured by Philips / Lifeline Systems, Inc..
[115532984]
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: 1840549, 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
| Report Number | MW5078663 |
| MDR Report Key | 7731039 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-07 |
| Date of Event | 2018-06-28 |
| Date Added to Maude | 2018-07-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHILIPS LIFELINE |
| Generic Name | SYSTEM, COMMUNICATION, POWERED |
| Product Code | ILQ |
| Date Received | 2018-07-27 |
| Model Number | 6900AT |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS / LIFELINE SYSTEMS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening; 4. Deathisabilit | 2018-07-27 |