MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for STANLEY M200 manufactured by Stanley Security Solutions, Inc..
[145369830]
Stanley bed alarm on patient for the purpose of alarming for fall prevention. Patient fell, bed alarm did not ring the alarm. Stanley rep contacted by nurse manager. Discovered the black cord used with the alarm was broken. Rep indicated this has happened before with this cord.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8619323 |
| MDR Report Key | 8619323 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-09 |
| Report Date | 2019-04-10 |
| Date Reported to FDA | 2019-04-10 |
| Date Reported to Mfgr | 2019-05-17 |
| Date Added to Maude | 2019-05-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | STANLEY M200 |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2019-05-17 |
| Model Number | M200 |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS, INC. |
| Manufacturer Address | 4600 VINE ST LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-17 |