MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-06-20 for LIFELINE PERSONAL RESPONSE SYSTEM C6804 manufactured by Lifeline Systems, Inc..
[47762442]
The subscriber had been on service since 2008. There was no record of her depressing the personal help button (phb) during the event to summon help. The involved button has not been returned for evaluation as the family stated the button was not in their possession. The subscriber had a traditional (phb). This subscriber received a mailing in oct. 2009 entitled, important information regarding the wearing method of your personal help button in 2009. This alerted her to the fact that any button worn around the neck poses a choking hazard and gave the subscriber the option to switch to a wrist style phb free of charge. In 2013 the subscriber received a replacement button. The caution card that ships with the button, part number 09303793, caution important safety information states, "to reduce any risk of strangulation, philips lifeline neck cords are designed to break apart under certain conditions. However, any cord worn around the neck can pose a strangulation risk, including the possibility of death and serious injuries. This may be of more concern to wearers in wheelchairs, using walkers, using beds with guard rails, or who might encounter other protruding objects upon which the cord can become tangled. Wearers for whom this is a concern may wish to consider the wristband style button. " the reporter stated that the neck cord had a knot tied near the breakaway fuse. Available information supports the alteration prevented the breakaway from deploying. This appears to be a very unfortunate accident. In the event the manufacturer obtains more information regarding this event, a follow up report will be sent. Not in possession of family.
Patient Sequence No: 1, Text Type: N, H10
[47762443]
The caller stated his mother-in-law was found with the neck cord of her personal help button (phb) entangled on her walker. He stated the neck cord appeared to have a breakaway design but a knot had been tied near the breakaway fuse.
Patient Sequence No: 1, Text Type: D, B5
[58464815]
On sept. 28, 2016, the manufacturer received a copy of the report of the investigation conducted by the office of the (b)(6) coroner. The report (which is in the (b)(6) language) concludes that the death in question was an accidental death.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220762-2016-00001 |
| MDR Report Key | 5736233 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-06-20 |
| Date of Report | 2016-06-20 |
| Date of Event | 2016-05-14 |
| Date Mfgr Received | 2016-09-28 |
| Date Added to Maude | 2016-06-20 |
| 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 01701 |
| Manufacturer Country | US |
| Manufacturer Postal | 01701 |
| Manufacturer Phone | 5089881079 |
| Manufacturer G1 | LIFELINE SYSTEMS, INC. |
| Manufacturer Street | 111 LAWRENCE ST. |
| Manufacturer City | FRAMINGHAM MA 01701 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01701 |
| 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 |
| Product Code | ILQ |
| Date Received | 2016-06-20 |
| Model Number | C6804 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFELINE SYSTEMS, INC. |
| Manufacturer Address | 111 LAWRENCE ST. FRAMINGHAM MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-06-20 |