MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-15 for STANLEY M200 manufactured by Stanley Security Solutions.
[108518234]
Patient heard to be moaning and rn found patient on floor in front of the chair. Patient on chair alarm which did not sound. Chair alarm and chair pad replaced. Noted to have been a malfunction of the chair alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077239 |
| MDR Report Key | 7518141 |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-05-10 |
| Date Added to Maude | 2018-05-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | STANLEY M200 |
| Generic Name | CHAIR ALARM |
| Product Code | KMI |
| Date Received | 2018-05-15 |
| Model Number | M200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS |
| Brand Name | STANLEY M200 |
| Generic Name | CHAIR ALARM |
| Product Code | KMI |
| Date Received | 2018-05-15 |
| Model Number | M200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY INDUSTRIAL AND AUTOMOTIVE LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-05-15 |