MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2013-07-01 for LIFELINE PERSONAL RESPONSE SYSTEM C6804 manufactured by .
[3596198]
Reporter stated her mother appears to have stumbled while walking, with a walker, from her kitchen area to her bedroom. In the course of her fall, her pendant personal help button (phb), with a non-break away cord, caught on one of the walker handles. The medical examiner concluded that she was rendered unconscious and died by asphyxia.
Patient Sequence No: 1, Text Type: D, B5
[10965629]
It does not appear from available info there was any malfunctions of the device. Our records do not indicate the subscriber initiated a help call during the time of the event. A caution had been provided to the customer via a mailing directly from philips lifeline (b)(4) in (b)(6) 2009, entitled important safety info regarding the wearing method of your lifeline personal help button and excerpt below. "caution: the pendant's neck cord is not designed to break away. Therefore, it can pose a choking risk, including the possibility of death and serious injuries. This may apply 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 wrist style method. In the event that additional info is obtained, a supplemental report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220762-2013-00001 |
| MDR Report Key | 3229624 |
| Report Source | 01,04 |
| Date Received | 2013-07-01 |
| Date of Report | 2013-06-06 |
| Date of Event | 2013-02-19 |
| Date Mfgr Received | 2013-06-06 |
| Date Added to Maude | 2013-07-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | INGRID SAWVELLE |
| Manufacturer Street | 111 LAWRENCE ST. |
| Manufacturer City | FRAMINGHAM MA 01702 |
| Manufacturer Country | US |
| Manufacturer Postal | 01702 |
| Manufacturer Phone | 5089881079 |
| 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 | 2013-07-01 |
| Model Number | C6804 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-07-01 |