MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2013-12-18 for LIFELINE PERSONAL RESPONSE SYSTEM FD100 manufactured by .
[21273304]
The subscriber's injury was a result of a fall down a stair well. The involved equipment (model fd100) was not the cause of the fall. The fd100 is not labeled as a life sustaining device. The involved equipment was returned for eval and it was determined that the battery on the subscriber's fd100 was depleted. The fd100 has a low battery detection algorithm which is a time-based series of internal voltage checks which takes 24 hrs to complete. In this case, the battery depletion was too rapid which resulted in depletion before the fd100 algorithm could complete its internal voltage checks. Consequently, no low battery signal was sent to the response center to trigger the fd100 replacement process. Subscribers are also automatically reminded to test their equipment every month to detect any issues.
Patient Sequence No: 1, Text Type: N, H10
[21496619]
Subscriber had fallen in the stair well and his autoalert help button did not signal. He was found the next day by a home support worker. It was indicated that the subscriber had a broken hip and was hospitalized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220762-2013-00002 |
| MDR Report Key | 3534177 |
| Report Source | 01,04,07 |
| Date Received | 2013-12-18 |
| Date of Report | 2013-11-18 |
| Date of Event | 2013-11-15 |
| Date Mfgr Received | 2013-11-18 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-01-09 |
| 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 | 2013-12-18 |
| Returned To Mfg | 2013-12-09 |
| Model Number | FD100 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-12-18 |