MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2008-11-04 for HEALTH WATCH PERSONAL RESPONSE SYSTEM HW6000 manufactured by .
[989586]
A letter from the device user's/wearer's lawyer stated the user fell in her wheelchair without depressing her personal help button. The letter alleges the neck cord to the personal help button became caught on the wheelchair, resulting in the wearer's death.
Patient Sequence No: 1, Text Type: D, B5
[8244054]
The subscriber did not press her personal help button during the fall. Available information indicates there was no malfunction of the device. This appears to be a very unfortunate accident. This manufacturer is no longer manufacturing and distributing product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1054748-2008-00001 |
| MDR Report Key | 1230583 |
| Report Source | 00,04 |
| Date Received | 2008-11-04 |
| Date of Report | 2008-11-04 |
| Date of Event | 2006-10-06 |
| Date Mfgr Received | 2008-10-06 |
| Date Added to Maude | 2008-11-19 |
| 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 JOHNSON |
| 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 | HEALTH WATCH PERSONAL RESPONSE SYSTEM |
| Generic Name | SYSTEM, COMMUNICATION, POWERED |
| Product Code | IQA |
| Date Received | 2008-11-04 |
| Model Number | HW6000 |
| Catalog Number | HW6000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1284582 |
| Manufacturer Address | 6400 PARK OF COMMERCE BLVD SUITE 1 BOCA RATON FL 33487 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-11-04 |