MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for STANLEY M200 manufactured by Stanley Security Solutions, Inc..
[109397036]
Patient Sequence No: 1, Text Type: N, H10
[109397037]
The alarm mat connection port at the bottom of the box did not allow the connection to click in and lock in. It did accept the cable, and the cable sound indicator sounded as though the connection was made between the mat under the patient and the alarm box. With any slight movement of the cable or even gravity for any period of time, the connector slips out of the alarm box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7548636 |
| MDR Report Key | 7548636 |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-05-15 |
| Report Date | 2018-05-22 |
| Date Reported to FDA | 2018-05-22 |
| Date Reported to Mfgr | 2018-05-22 |
| Date Added to Maude | 2018-05-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | STANLEY M200 |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-05-29 |
| Model Number | M200 |
| ID Number | BOX 209787 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS, INC. |
| Manufacturer Address | 4600 VINE STREET LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-29 |