MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-14 for STANLEY M200 manufactured by Stanley Security Solutions.
[108533422]
Chair alarm malfunctioned. When patient stood up, the chair alarm "set" as if the patient was sitting down instead of sounding off. When the patient sat back down the chair alarm then sounded off instead of setting the alarm. This product has already been returned to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077241 |
| MDR Report Key | 7518145 |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-05-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | STANLEY CHAIR ALARM/PAD |
| Product Code | KMI |
| Date Received | 2018-05-14 |
| Returned To Mfg | 2018-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS |
| Brand Name | STANLEY M200 |
| Generic Name | STANLEY CHAIR ALARM/PAD |
| Product Code | KMI |
| Date Received | 2018-05-14 |
| Returned To Mfg | 2018-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY INDUSTRIAL AND AUTOMOTIVE LLC |
| Manufacturer Address | PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-05-14 |